29 Senior Pharmaceutical Quality Assurance Specialist Remote jobs in whatjobs

Senior Pharmaceutical Quality Assurance Specialist (Remote)

50200 Tuwan KES130000 Annually WhatJobs

Posted 21 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a highly meticulous and experienced Senior Pharmaceutical Quality Assurance Specialist to join their dedicated, remote-first quality assurance team. This critical role will focus on ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be instrumental in developing, implementing, and maintaining robust quality management systems, conducting audits, and driving continuous improvement initiatives. The ideal candidate possesses a deep understanding of pharmaceutical manufacturing processes, regulatory guidelines (e.g., GMP, ICH), and quality control principles, coupled with the ability to manage these responsibilities effectively in a remote setting.

Key responsibilities include:
  • Developing, implementing, and maintaining the company's Quality Management System (QMS).
  • Ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory standards.
  • Conducting internal and external audits of manufacturing sites, suppliers, and contract manufacturers.
  • Reviewing and approving batch records, validation protocols, and technical documentation.
  • Investigating deviations, out-of-specification (OOS) results, and customer complaints, and implementing corrective and preventive actions (CAPA).
  • Participating in regulatory inspections and providing necessary documentation and support.
  • Developing and delivering quality assurance training to relevant personnel.
  • Monitoring and analyzing quality metrics to identify trends and areas for improvement.
  • Contributing to product lifecycle management and change control processes.
  • Staying up-to-date with evolving pharmaceutical regulations and industry best practices.
The ideal candidate will hold a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. You should have 5-7 years of progressive experience in pharmaceutical quality assurance or quality control. In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory frameworks is essential. Proven experience with audits, deviation investigations, CAPA management, and validation processes is required. Excellent analytical, problem-solving, and documentation skills are crucial. Strong written and verbal communication skills, with the ability to interact effectively with cross-functional teams and regulatory authorities, are necessary. Experience working in a remote quality assurance role and proficiency with quality management software are highly desirable. This role is notionally based in Bungoma, Bungoma, KE , but is a fully remote opportunity.
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Senior Pharmaceutical Quality Assurance Specialist (Remote)

80200 Shella KES180000 Annually WhatJobs

Posted 21 days ago

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Job Description

full-time
Our client, a rapidly growing pharmaceutical company, is seeking a highly motivated and detail-oriented Senior Pharmaceutical Quality Assurance Specialist to join their expanding operations. This is a unique opportunity to contribute to the development and manufacturing of high-quality pharmaceutical products from a remote location. You will be responsible for ensuring compliance with all relevant regulatory standards, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Your role will involve overseeing quality control processes, conducting internal audits, and managing external audits from regulatory bodies. You will play a crucial part in the validation of manufacturing processes, equipment, and analytical methods. Developing and implementing quality management systems, writing and revising Standard Operating Procedures (SOPs), and investigating deviations and out-of-specification (OOS) results are key responsibilities. The ideal candidate will have a strong understanding of pharmaceutical regulatory affairs and a proven track record in quality assurance within the pharmaceutical industry. Experience with pharmacovigilance and adverse event reporting is a significant advantage. This position requires exceptional analytical and problem-solving abilities, meticulous attention to detail, and the capacity to work autonomously while collaborating effectively with cross-functional teams. You will be instrumental in fostering a culture of quality and continuous improvement throughout the organization, ensuring the safety and efficacy of our client's products. The ability to interpret complex regulatory guidelines and apply them practically is essential. This remote role offers the chance to make a substantial impact on public health by upholding the highest quality standards in pharmaceutical production, regardless of your physical location within Kenya, contributing to our client’s mission in **Malindi, Kilifi, KE** and beyond.

Responsibilities:
  • Ensure adherence to GMP, GLP, and other relevant pharmaceutical regulations.
  • Develop, implement, and maintain Quality Management Systems (QMS).
  • Conduct internal audits and support external regulatory inspections.
  • Manage deviations, CAPAs (Corrective and Preventive Actions), and OOS investigations.
  • Validate manufacturing processes, analytical methods, and equipment.
  • Review and approve batch records, specifications, and other quality-related documents.
  • Write, revise, and implement SOPs and quality guidelines.
  • Participate in change control procedures and risk assessments.
  • Monitor and report on key quality metrics and performance indicators.
  • Provide training to personnel on quality assurance principles and GMP compliance.
  • Liaise with regulatory authorities and respond to queries.
  • Contribute to the continuous improvement of quality processes.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
  • Minimum of 5 years of experience in pharmaceutical quality assurance or quality control.
  • In-depth knowledge of GMP, ICH guidelines, and pharmaceutical regulatory requirements.
  • Proven experience with audits, validation, and quality management systems.
  • Strong understanding of pharmaceutical manufacturing processes and analytical techniques.
  • Excellent documentation, investigation, and problem-solving skills.
  • Proficiency in data analysis and interpretation.
  • Strong communication and interpersonal skills, with the ability to present information clearly.
  • Experience working in a remote or hybrid team environment is a plus.
  • Proactive attitude towards identifying and resolving quality issues.
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Senior Pharmaceutical Quality Assurance Specialist (Remote)

20100 Mwembe KES110000 Annually WhatJobs

Posted 21 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a highly experienced and detail-oriented Senior Pharmaceutical Quality Assurance Specialist to join their fully remote team. This critical role will be instrumental in ensuring the highest standards of quality and compliance throughout the pharmaceutical product lifecycle, from development to post-market surveillance. The ideal candidate will possess a deep understanding of regulatory requirements, GMP (Good Manufacturing Practices), GCP (Good Clinical Practices), and GXP (Good Practices) guidelines, along with a proven track record in pharmaceutical quality assurance.

You will be responsible for developing, implementing, and maintaining robust quality systems. This includes conducting internal audits, investigating deviations and out-of-specification (OOS) results, and implementing corrective and preventive actions (CAPAs). The Senior QA Specialist will review and approve critical documentation, such as batch records, validation protocols, and SOPs. You will also play a key role in managing regulatory inspections and ensuring compliance with global health authority requirements (e.g., FDA, EMA). Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality is integrated into all processes will be paramount. This position requires strong analytical skills, excellent problem-solving abilities, and meticulous attention to detail. As a fully remote role, exceptional self-management, communication, and proficiency in digital collaboration tools are essential. You will contribute significantly to the safety and efficacy of pharmaceutical products. Join a dedicated team committed to advancing healthcare through unwavering quality and compliance. While the company has operations in **Naivasha, Nakuru, KE**, this role is fully remote, offering significant flexibility and broad impact.

Responsibilities:
  • Develop, implement, and maintain pharmaceutical quality assurance systems.
  • Conduct internal audits and supplier audits to ensure compliance.
  • Investigate deviations, OOS results, and customer complaints.
  • Develop and implement CAPA plans.
  • Review and approve critical quality documents (batch records, SOPs, validation protocols).
  • Ensure compliance with GMP, GCP, and other relevant GXP regulations.
  • Support regulatory inspections and respond to agency inquiries.
  • Collaborate with cross-functional teams to maintain quality standards.
  • Contribute to the continuous improvement of quality processes.
  • Provide training on quality systems and regulatory requirements.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
  • Minimum of 7 years of experience in pharmaceutical quality assurance.
  • In-depth knowledge of GMP, GCP, and other relevant GXP regulations.
  • Proven experience with quality systems, audits, and investigations (deviations, CAPAs).
  • Excellent analytical, problem-solving, and documentation skills.
  • Strong understanding of pharmaceutical manufacturing processes and product lifecycle.
  • Exceptional communication and interpersonal abilities.
  • Ability to work independently and manage responsibilities effectively in a remote environment.
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Senior Pharmaceutical Quality Assurance Specialist - Remote

70100 Abothuguchi West KES330000 Annually WhatJobs

Posted 21 days ago

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Job Description

full-time
Our client, a reputable pharmaceutical entity, is seeking an experienced Senior Pharmaceutical Quality Assurance Specialist to join their team remotely. This role is integral to ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be responsible for developing, implementing, and maintaining quality assurance systems, conducting audits, and ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulations. The ideal candidate will have a deep understanding of pharmaceutical quality control, exceptional attention to detail, and the ability to manage quality processes effectively in a remote capacity.

Key Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS).
  • Ensure compliance with all applicable regulatory requirements, including GMP, GDP, and ICH guidelines.
  • Conduct internal and external audits of manufacturing sites, suppliers, and contract manufacturers.
  • Review and approve batch records, validation protocols, and other quality-related documentation.
  • Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPA).
  • Participate in regulatory inspections and prepare responses to regulatory queries.
  • Develop and deliver quality assurance training programs to relevant personnel.
  • Monitor and analyze quality metrics, providing reports on product quality and system performance.
  • Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality.
  • Manage change control processes and ensure proper documentation and impact assessments.
  • Stay up-to-date with evolving regulatory requirements and industry best practices.
  • Contribute to the continuous improvement of quality systems and processes.
  • Oversee the qualification and validation of equipment and processes.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
  • Minimum of 6 years of progressive experience in Quality Assurance within the pharmaceutical industry.
  • Strong knowledge of pharmaceutical manufacturing processes and quality control.
  • In-depth understanding of GMP, GLP, GDP, and other relevant regulatory guidelines.
  • Experience in conducting internal and external audits.
  • Excellent understanding of CAPA systems and change control processes.
  • Strong analytical, problem-solving, and decision-making skills.
  • Exceptional attention to detail and accuracy.
  • Excellent written and verbal communication skills.
  • Ability to work independently, manage multiple projects, and meet deadlines in a remote setting.
  • Familiarity with quality management software is a plus.
  • Experience supporting quality assurance for operations related to Garissa, Garissa, KE is beneficial.

This is a fully remote position. If you are a dedicated Quality Assurance professional seeking a challenging remote opportunity to uphold the highest pharmaceutical standards, we encourage you to apply.
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Senior Pharmaceutical Quality Assurance Specialist - Remote

01000 Makongeni KES200000 Annually WhatJobs

Posted 21 days ago

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Job Description

full-time
Our client, a leading pharmaceutical entity, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their dedicated quality team. This is a fully remote role, allowing you to contribute from any location. The successful candidate will play a critical role in ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements. Responsibilities include developing and implementing quality management systems, conducting internal audits, managing deviation investigations, and overseeing change control processes. You will also be responsible for reviewing batch records, ensuring compliance with Good Manufacturing Practices (GMP), and supporting regulatory inspections. A thorough understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control is essential. The ideal candidate will possess strong analytical skills, exceptional attention to detail, and the ability to interpret complex regulations. This role requires a proactive approach to quality assurance and the ability to drive continuous improvement initiatives within a remote setting. Excellent documentation and communication skills are vital for success.

Responsibilities:
  • Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP.
  • Conduct internal audits of manufacturing processes, facilities, and systems.
  • Investigate deviations, non-conformances, and out-of-specification results, ensuring root cause analysis and implementation of corrective and preventive actions (CAPA).
  • Manage the change control process, assessing the impact of changes on product quality and regulatory compliance.
  • Review and approve batch production records, ensuring adherence to established procedures.
  • Monitor and ensure compliance with all applicable regulatory requirements (e.g., FDA, EMA, WHO GMP).
  • Prepare for and support regulatory inspections and client audits.
  • Develop and deliver quality training programs to relevant personnel.
  • Stay updated on industry best practices and changes in regulatory guidelines.
  • Contribute to the validation of processes, equipment, and analytical methods.
  • Collaborate with R&D, production, and regulatory affairs departments to ensure product quality throughout the lifecycle.
  • Initiate and lead continuous improvement projects within the quality assurance framework.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Master's degree preferred.
  • Minimum of 7 years of progressive experience in pharmaceutical quality assurance or quality control.
  • In-depth knowledge of GMP, regulatory guidelines, and pharmaceutical manufacturing processes.
  • Proven experience in conducting audits, managing deviations, and implementing CAPA.
  • Strong understanding of validation principles and processes.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Meticulous attention to detail and strong documentation skills.
  • Ability to work independently, manage multiple projects, and meet deadlines in a remote environment.
  • Effective communication and interpersonal skills for collaboration with cross-functional teams.
  • Experience with electronic QMS and document control systems is desirable.
This critical remote role is based with our client in the pharmaceutical sector, serving the region around Thika, Kiambu, KE . If you are a dedicated QA professional, we invite you to apply.
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Senior Pharmaceutical Quality Assurance Specialist (Remote)

10100 Nyeri Town KES400000 Annually WhatJobs

Posted 21 days ago

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Job Description

full-time
Our client, a leading innovator in the pharmaceutical industry, is seeking a highly skilled and meticulous Senior Pharmaceutical Quality Assurance Specialist. This is a unique opportunity to contribute to critical quality control processes within a fully remote capacity. You will play a pivotal role in ensuring that our client's pharmaceutical products meet the highest standards of safety, efficacy, and regulatory compliance.

Responsibilities:
  • Develop, implement, and maintain the Quality Management System (QMS) in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
  • Conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers to ensure compliance.
  • Review and approve documentation, including batch records, validation protocols, SOPs, and change controls.
  • Investigate deviations, out-of-specification results, and customer complaints, implementing corrective and preventive actions (CAPAs).
  • Participate in regulatory inspections and respond to inquiries from health authorities.
  • Develop and deliver quality training programs to relevant personnel.
  • Monitor and analyze quality metrics, identifying trends and implementing continuous improvement initiatives.
  • Contribute to the risk assessment process for new product development and manufacturing processes.
  • Ensure that all pharmaceutical products are manufactured and tested according to approved procedures and specifications.
  • Stay up-to-date with evolving regulatory requirements and industry best practices.
  • Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality standards are met throughout the product lifecycle.
Qualifications:
  • A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is preferred.
  • Minimum of 6 years of experience in pharmaceutical quality assurance or quality control.
  • Extensive knowledge of GMP, GLP, ICH guidelines, and other relevant pharmaceutical regulations (e.g., FDA, EMA).
  • Proven experience in conducting audits, investigations, and implementing CAPAs.
  • Strong understanding of pharmaceutical manufacturing processes and analytical testing.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Exceptional attention to detail and organizational abilities.
  • Strong written and verbal communication skills, with the ability to clearly articulate complex quality issues.
  • Proficiency in QMS software and Microsoft Office Suite.
  • Ability to work independently and manage multiple projects effectively in a remote environment.
This remote role demands a rigorous approach to quality and a deep understanding of pharmaceutical regulations. The ideal candidate will be a proactive problem-solver, committed to upholding the highest standards of product quality and patient safety. Your expertise will be crucial in ensuring compliance and driving excellence in our client's pharmaceutical operations.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Quality Assurance Specialist - Remote

20400 Kapsuser KES3200000 Annually WhatJobs

Posted 21 days ago

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Job Description

full-time
Our client, a reputable pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their global, remote-first team. This critical role ensures that all pharmaceutical products meet the highest standards of quality, safety, and efficacy. You will be responsible for developing, implementing, and maintaining robust quality management systems, ensuring compliance with global regulatory requirements, including cGMP (current Good Manufacturing Practices). Working entirely remotely, you will conduct quality audits, review batch records, investigate deviations and out-of-specification (OOS) results, and implement corrective and preventive actions (CAPAs). Your expertise will be vital in ensuring product integrity throughout the manufacturing lifecycle. The ideal candidate possesses a deep understanding of pharmaceutical manufacturing processes, quality control principles, and regulatory affairs. Experience with validation processes (process, cleaning, analytical methods) is essential. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments to resolve quality issues and drive continuous improvement. This position demands exceptional analytical, problem-solving, and documentation skills. The ability to interpret complex technical data, communicate findings clearly and effectively to diverse stakeholders, and maintain meticulous records is paramount. A strong sense of ownership, attention to detail, and the ability to work independently and manage priorities in a fully remote setting are crucial for success. You will also contribute to the training of QA personnel and the development of SOPs.
Responsibilities:
  • Oversee and maintain the Quality Management System (QMS) for pharmaceutical operations.
  • Ensure compliance with cGMP, ICH, and other relevant regulatory guidelines.
  • Conduct internal and external quality audits of suppliers and manufacturing sites.
  • Review and approve batch production and control records.
  • Investigate deviations, out-of-specification results, and customer complaints.
  • Develop and implement corrective and preventive actions (CAPAs).
  • Manage the validation of processes, equipment, and analytical methods.
  • Review and approve documentation such as SOPs, protocols, and validation reports.
  • Support regulatory inspections and submissions.
  • Train and mentor junior QA personnel.
Qualifications:
  • Master's degree or PhD in Pharmacy, Chemistry, Microbiology, or a related life science field.
  • Minimum of 7 years of experience in pharmaceutical Quality Assurance or Quality Control.
  • In-depth knowledge of cGMP, ICH guidelines, and global pharmaceutical regulations.
  • Experience with pharmaceutical manufacturing processes and quality control testing.
  • Proficiency in quality risk management principles and tools.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Excellent written and verbal communication skills, with a high level of attention to detail.
  • Demonstrated ability to work independently and manage multiple projects effectively in a remote environment.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Quality Assurance Specialist - Remote

20200 Kapsuser KES160000 Annually WhatJobs

Posted 21 days ago

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Job Description

full-time
Our client is actively seeking a highly skilled and experienced Senior Pharmaceutical Quality Assurance Specialist to join their fully remote team. In this critical position, you will play a key role in ensuring the quality, safety, and efficacy of pharmaceutical products by upholding stringent regulatory standards and internal quality systems. You will be responsible for developing, implementing, and maintaining quality assurance protocols, conducting audits, reviewing batch records, and managing deviation investigations. This is an excellent opportunity for a meticulous professional to contribute to the pharmaceutical industry from the comfort of their home office, working with a global perspective.

Key Responsibilities:
  • Develop, implement, and maintain Quality Assurance (QA) systems and procedures in compliance with cGMP, FDA, EMA, and other relevant regulatory requirements.
  • Conduct internal and external audits of manufacturing facilities, suppliers, and vendors to ensure compliance.
  • Review and approve batch production and control records, product release documentation, and stability data.
  • Investigate deviations, out-of-specifications (OOS) results, and customer complaints, implementing corrective and preventative actions (CAPAs).
  • Participate in the validation and qualification of manufacturing processes, equipment, and analytical methods.
  • Prepare and present QA reports to management, highlighting quality metrics, trends, and areas for improvement.
  • Collaborate with R&D, manufacturing, regulatory affairs, and other departments to ensure seamless product development and lifecycle management.
  • Contribute to the development and execution of quality risk management strategies.
  • Train personnel on quality systems and cGMP principles.
  • Stay abreast of evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.

Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is a plus.
  • A minimum of 6 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
  • In-depth knowledge of cGMP regulations, ICH guidelines, and pharmaceutical quality systems.
  • Proven experience in conducting audits, managing deviations, and implementing CAPAs.
  • Strong understanding of pharmaceutical manufacturing processes and analytical testing.
  • Excellent documentation and technical writing skills.
  • Exceptional analytical and problem-solving abilities.
  • Strong interpersonal and communication skills, with experience working effectively in a remote team environment.
  • Ability to manage multiple projects and priorities simultaneously.
  • Experience with electronic quality management systems (eQMS) is advantageous.

This position is entirely remote, offering you the flexibility to work from your preferred location while contributing to quality standards that are conceptually aligned with the pharmaceutical landscape around **Kericho, Kericho, KE**. Join a dedicated team focused on ensuring the highest quality in pharmaceutical products.
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Senior Pharmaceutical Quality Assurance Specialist (Remote)

60100 Embu, Eastern KES260000 Annually WhatJobs

Posted 16 days ago

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Job Description

full-time
Our client, a rapidly expanding pharmaceutical company dedicated to advancing global health, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their robust remote team. This critical role involves overseeing and implementing comprehensive quality assurance strategies across all aspects of pharmaceutical manufacturing and development. As a fully remote professional, you will play a pivotal role in ensuring compliance with stringent regulatory standards, driving continuous improvement, and maintaining the highest levels of product integrity. The ideal candidate will possess a deep understanding of GxP regulations and a proven ability to manage quality systems effectively from a distance.

Responsibilities:
  • Develop, implement, and maintain quality assurance systems and procedures in line with GxP regulations (GMP, GCP, GLP).
  • Conduct internal and external audits of manufacturing facilities, suppliers, and contract research organizations.
  • Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
  • Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
  • Monitor and analyze quality metrics, identifying trends and areas for improvement.
  • Prepare for and participate in regulatory inspections by agencies such as the FDA, EMA, and local health authorities.
  • Ensure compliance with global pharmaceutical regulations and industry best practices.
  • Provide quality oversight for product development, manufacturing, and lifecycle management.
  • Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain.
  • Manage change control processes to ensure that changes do not adversely impact product quality.
  • Contribute to the continuous improvement of the quality management system.
  • Effectively communicate quality requirements and expectations to internal and external stakeholders in a remote setting.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
  • Minimum of 6-8 years of experience in pharmaceutical quality assurance or quality control.
  • In-depth knowledge of GxP regulations and pharmaceutical manufacturing processes.
  • Proven experience in conducting and managing audits and regulatory inspections.
  • Strong understanding of quality risk management principles.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Exceptional written and verbal communication skills, with the ability to articulate complex quality issues.
  • Proficiency in quality management software and electronic document control systems.
  • Demonstrated ability to work independently and manage responsibilities effectively in a remote work environment.
  • Experience with cross-functional team collaboration in a remote setting is essential.
  • Professional certifications in Quality Assurance (e.g., ASQ) are a plus.

This remote position supports our client's operations which are closely linked to **Embu, Embu, KE**, offering a critical role in ensuring the quality and safety of life-saving medications. If you are a dedicated QA professional passionate about maintaining the highest standards in the pharmaceutical industry, we encourage you to apply.
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Senior Pharmaceutical Quality Assurance Specialist (Remote)

00201 Ongata Rongai, Rift Valley KES160000 Annually WhatJobs

Posted 15 days ago

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Job Description

full-time
Our client is seeking a highly skilled and meticulous Senior Pharmaceutical Quality Assurance Specialist to join their fully remote team. This critical role is essential for ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements, with a strategic operational focus connected to Ongata Rongai, Kajiado, KE . You will be responsible for developing, implementing, and maintaining the quality management system (QMS), conducting internal and external audits, and ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulations. Key duties include reviewing and approving batch records, investigating deviations and out-of-specification results, and managing change control processes. You will also be involved in supplier qualification, risk assessment, and the development of validation protocols. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes and quality control methodologies. Strong analytical, problem-solving, and critical thinking skills are paramount, along with excellent attention to detail. Proven experience in pharmaceutical quality assurance, regulatory affairs, or a related field is required. Proficiency in quality management software and a thorough knowledge of international regulatory guidelines (e.g., FDA, EMA) are essential. This remote position demands a high degree of self-motivation, excellent communication skills, and the ability to manage complex quality assurance tasks effectively from a distance. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is a prerequisite, along with significant professional experience. We are looking for a dedicated quality professional who can champion best practices and contribute to the integrity and success of our client's pharmaceutical operations.
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