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Showing 5000+ Quality Control Systems jobs in Kenya

Lead Pharmaceutical Quality Assurance Specialist

00511 Ongata Rongai, Rift Valley KES350000 Annually WhatJobs Direct remove_red_eye View All

Posted 2 days ago

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Job Description

full-time
Our client, a pioneering pharmaceutical company committed to advancing global health, is looking for a dedicated and highly skilled Lead Pharmaceutical Quality Assurance Specialist. This is a critical, fully remote role, allowing you to contribute to our client's mission from any location in Kenya. You will be instrumental in upholding the highest standards of quality and compliance across all pharmaceutical operations. The Lead QA Specialist will be responsible for developing, implementing, and maintaining robust quality management systems that align with international regulatory requirements, including GMP, GLP, and GCP. Your duties will encompass conducting internal audits, investigating deviations and CAPAs, managing change controls, and ensuring all documentation is accurate, complete, and compliant. You will also play a key role in preparing for and supporting external regulatory inspections and audits. This position demands meticulous attention to detail, a comprehensive understanding of pharmaceutical manufacturing processes, and expertise in quality control methodologies. The ideal candidate will possess strong analytical and problem-solving skills, coupled with excellent communication and interpersonal abilities to effectively collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs. As a remote employee, you will leverage advanced digital collaboration tools to maintain seamless communication and project progress. A proactive approach to identifying and mitigating risks within the quality framework is crucial. This role offers a unique opportunity to shape the quality culture of a growing pharmaceutical entity and contribute to the development of life-saving medicines. If you are a seasoned QA professional with a passion for excellence and the ability to thrive in a remote work environment, we invite you to apply for this impactful position. This role is based in **Ongata Rongai, Kajiado, KE**.
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Pharmaceutical Quality Assurance Specialist

30400 Tuwan KES720000 Annually WhatJobs Direct remove_red_eye View All

Posted 2 days ago

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Job Description

full-time
Our client, a reputable pharmaceutical firm, is seeking a meticulous and detail-oriented Pharmaceutical Quality Assurance Specialist to join their dedicated team. This is an on-site position critical for upholding the highest standards of quality and compliance within their manufacturing and operational processes. The ideal candidate will possess a robust understanding of pharmaceutical quality systems, regulatory affairs, and Good Manufacturing Practices (GMP). You will be instrumental in ensuring that all products meet stringent quality specifications and regulatory requirements.

Key responsibilities include developing, implementing, and maintaining quality assurance programs and procedures. You will conduct internal audits, review batch records, manage deviations and change controls, and participate in regulatory inspections. The role involves collaborating with various departments, including R&D, manufacturing, and quality control, to ensure seamless integration of quality into all processes. Experience in quality risk management and CAPA (Corrective and Preventive Actions) implementation is essential. You will play a vital role in ensuring the safety, efficacy, and consistency of pharmaceutical products. This position demands exceptional analytical skills, strong problem-solving capabilities, and a commitment to continuous improvement. The ability to interpret complex regulations and apply them effectively in a practical setting is paramount. You will contribute significantly to maintaining our client's reputation for excellence and compliance. This is a key role located within our facilities at Kitale, Trans-Nzoia, KE .

Key Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS).
  • Conduct internal audits and inspections to ensure compliance with GMP and regulatory standards.
  • Review and approve batch records, specifications, and validation documents.
  • Manage deviations, out-of-specification (OOS) results, and change control processes.
  • Participate in external audits and inspections by regulatory authorities.
  • Collaborate with manufacturing, R&D, and QC departments to resolve quality issues.
  • Implement CAPA (Corrective and Preventive Actions) to address quality deficiencies.
  • Stay up-to-date with relevant pharmaceutical regulations and industry best practices.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.
  • 3+ years of experience in pharmaceutical quality assurance or quality control.
  • Thorough understanding of GMP, ISO standards, and regulatory requirements (e.g., FDA, EMA).
  • Experience with QMS, audits, deviation management, and CAPA.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
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Principal Pharmaceutical Quality Assurance Specialist

00200 Ongata Rongai, Rift Valley KES320000 Annually WhatJobs Direct remove_red_eye View All

Posted 2 days ago

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Job Description

full-time
Our client is seeking a highly experienced and motivated Principal Pharmaceutical Quality Assurance Specialist to lead and enhance their quality systems. This is a fully remote, critical role, offering the flexibility to work from anywhere while maintaining the highest standards of pharmaceutical product quality and compliance. You will be responsible for developing, implementing, and maintaining robust quality assurance programs, ensuring adherence to global regulatory requirements (e.g., FDA, EMA, WHO GMP). Your expertise will be vital in overseeing all aspects of quality control, risk management, and continuous improvement initiatives within the pharmaceutical manufacturing lifecycle. This role requires a deep understanding of pharmaceutical regulations, quality management systems, and a proactive approach to ensuring product safety and efficacy.

Key Responsibilities:
  • Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with cGMP, ICH, and other relevant regulatory guidelines.
  • Oversee and manage quality assurance activities, including batch record review, deviation investigation, CAPA management, and change control.
  • Conduct internal and external audits (supplier audits) to ensure compliance with regulatory standards and company policies.
  • Develop and implement validation strategies for manufacturing processes, equipment, and analytical methods.
  • Prepare and review regulatory submission documents related to quality aspects.
  • Lead and participate in regulatory inspections by health authorities, ensuring successful outcomes.
  • Develop and deliver training programs on quality assurance principles and regulatory compliance for relevant personnel.
  • Identify quality risks and implement effective risk mitigation strategies throughout the product lifecycle.
  • Analyze quality data to identify trends, root causes of deviations, and areas for improvement.
  • Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure seamless integration of quality considerations into all project phases.

Qualifications:
  • Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 10 years of progressive experience in pharmaceutical quality assurance and quality control, with at least 5 years in a leadership or principal specialist role.
  • In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements in major markets (US, EU, etc.).
  • Proven experience in developing and managing comprehensive QMS, including OOS investigations, CAPA, and change control.
  • Strong experience with audits (internal, external, regulatory) and regulatory submissions.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Exceptional written and verbal communication skills, with the ability to effectively present complex information to diverse audiences.
  • Demonstrated ability to lead teams and drive quality initiatives in a remote setting.
  • Proficiency in using quality management software and data analysis tools.
  • Strong understanding of pharmaceutical manufacturing processes and technologies.
This is a senior-level opportunity to shape quality standards. The role is based in Ongata Rongai, Kajiado, KE , but is fully remote.
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Pharmaceutical Quality Assurance Specialist

20100 Mwembe KES500000 Annually WhatJobs Direct

Posted 5 days ago

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Job Description

full-time
Our client is seeking a meticulous and experienced Pharmaceutical Quality Assurance Specialist to join their fully remote Quality department. This role is integral to ensuring that all pharmaceutical products meet stringent quality standards and regulatory compliance requirements. The Quality Assurance Specialist will be responsible for developing, implementing, and maintaining quality management systems (QMS), including SOPs, batch record review, and deviation investigations. You will play a key role in conducting internal audits, supplier audits, and ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations. The successful candidate will possess a strong understanding of pharmaceutical manufacturing processes, quality control methodologies, and regulatory affairs. This is a remote-first position, requiring exceptional organizational skills, attention to detail, and the ability to manage complex documentation and processes independently. Strong analytical and problem-solving skills are essential for investigating quality issues and implementing corrective and preventive actions (CAPA). Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, will be crucial. This is an excellent opportunity for a dedicated QA professional to contribute to the safety and efficacy of pharmaceutical products within a flexible, remote work environment. The role demands a proactive approach to identifying potential quality risks and implementing robust solutions to mitigate them, ensuring adherence to the highest industry standards. The position is focused on supporting operations near Nakuru, Nakuru, KE , but is operated entirely remotely.

Responsibilities:
  • Develop and maintain the Quality Management System (QMS), including SOPs and work instructions.
  • Conduct batch record reviews and ensure compliance with regulatory requirements.
  • Investigate deviations, customer complaints, and Out-of-Specification (OOS) results.
  • Implement and manage Corrective and Preventive Actions (CAPA).
  • Perform internal audits and support external audits by regulatory agencies.
  • Evaluate and qualify suppliers to ensure quality standards are met.
  • Monitor and analyze quality metrics and trends to identify areas for improvement.
  • Ensure compliance with GMP, GDP, and other relevant pharmaceutical regulations.
  • Provide training to personnel on quality standards and procedures.
  • Stay updated on regulatory changes and industry best practices.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • 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 in QMS implementation, SOP development, and batch record review.
  • Strong understanding of pharmaceutical manufacturing processes.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Proficiency in quality investigation techniques and CAPA management.
  • Strong written and verbal communication skills for documentation and interdepartmental collaboration.
  • Ability to work independently and manage multiple projects in a remote setting.
  • Attention to detail and a commitment to maintaining high-quality standards.
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Senior Pharmaceutical Quality Assurance Specialist

40205 Ongata Rongai, Rift Valley KES160000 Annually WhatJobs Direct remove_red_eye View All

Posted 2 days ago

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Job Description

full-time
Our client is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their fully remote team. This critical role will oversee and maintain the highest standards of quality across all pharmaceutical manufacturing and development processes. You will be responsible for ensuring compliance with all relevant regulatory requirements (e.g., GMP, FDA, EMA) and internal quality policies. Your expertise will be vital in developing, implementing, and managing robust quality systems that guarantee the safety, efficacy, and purity of pharmaceutical products. This is a remote-first position, requiring a self-starter with exceptional attention to detail and a strong understanding of the pharmaceutical lifecycle.

Key responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with global regulatory standards.
  • Conduct internal audits and inspections of manufacturing sites, laboratories, and processes to ensure compliance.
  • Review and approve batch records, validation protocols, and other critical quality documentation.
  • Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.
  • Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure quality is integrated throughout product development and lifecycle management.
  • Investigate product complaints and quality incidents, identifying root causes and implementing effective solutions.
  • Prepare for and support external regulatory inspections and audits by health authorities.
  • Contribute to the development and delivery of quality training programs for personnel.
  • Stay current with evolving pharmaceutical regulations and industry best practices.
  • Provide expert guidance and support to cross-functional teams on quality-related matters.
  • Evaluate and qualify raw material suppliers and contract manufacturing organizations.

The ideal candidate will hold a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A minimum of 7 years of progressive experience in pharmaceutical quality assurance and quality control is required, with a deep understanding of GMP regulations. Proven experience in auditing, QMS implementation, and regulatory compliance is essential. Excellent analytical, problem-solving, and decision-making skills are necessary, as are strong written and verbal communication abilities. The ability to work independently, manage multiple projects simultaneously, and collaborate effectively in a remote environment is crucial. Experience with electronic QMS platforms is a plus. This is a significant opportunity to shape quality strategies within a growing pharmaceutical organization, contributing directly to patient safety and product excellence. The role is based remotely within the general operational area of Ongata Rongai, Kajiado, KE .
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Pharmaceutical Quality Assurance Specialist (Remote)

30100 Moiben KES200000 Annually WhatJobs Direct

Posted 2 days ago

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Job Description

full-time
Our client is seeking a detail-oriented and experienced Pharmaceutical Quality Assurance Specialist to join their remote team. This role is crucial for ensuring compliance with regulatory standards and maintaining the highest quality in pharmaceutical products and processes. You will be responsible for developing, implementing, and monitoring quality assurance systems and procedures, all from a remote work environment. The ideal candidate will have a strong understanding of GMP (Good Manufacturing Practices), regulatory affairs, and quality control methodologies within the pharmaceutical industry.

Key Responsibilities:
  • Developing, implementing, and maintaining Quality Management Systems (QMS) in accordance with relevant pharmaceutical regulations.
  • Reviewing and approving batch records, manufacturing instructions, and validation protocols.
  • Conducting internal audits and supporting external audits by regulatory agencies and clients.
  • Investigating deviations, out-of-specification results, and customer complaints, and implementing corrective and preventive actions (CAPAs).
  • Monitoring and analyzing quality metrics, identifying trends, and recommending process improvements.
  • Ensuring all quality-related documentation is accurate, complete, and compliant.
  • Participating in the qualification and validation of equipment and processes.
  • Providing training on quality assurance principles and regulatory requirements to relevant personnel.
  • Staying current with evolving pharmaceutical regulations and industry best practices.
  • Collaborating with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure product quality and compliance.
This position is fully remote. While the work is remote, an awareness of the pharmaceutical landscape and regulatory considerations within regions such as Eldoret, Uasin Gishu, KE can be beneficial. Candidates should possess a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A minimum of 5 years of experience in pharmaceutical quality assurance is required. Comprehensive knowledge of cGMP, ICH guidelines, and other relevant regulatory requirements is essential. Experience with audit processes and CAPA management is mandatory. Excellent analytical, problem-solving, and documentation skills are critical. Strong communication and interpersonal skills are needed for effective collaboration with internal teams and external partners. Our client offers a competitive salary, comprehensive benefits, and opportunities for professional development within a flexible, remote work setting focused on innovation and quality.
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Lead Pharmaceutical Quality Assurance Specialist (Remote)

00100 Abothuguchi West KES6000000 Annually WhatJobs Direct remove_red_eye View All

Posted 2 days ago

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Job Description

full-time
Our client, a respected name in the pharmaceutical industry, is seeking a meticulous and experienced Lead Pharmaceutical Quality Assurance Specialist to oversee critical quality operations within their fully remote framework. This senior position involves ensuring compliance with all relevant regulatory standards (e.g., GMP, FDA, EMA) and maintaining the highest levels of product quality and integrity. You will be responsible for developing, implementing, and maintaining the Quality Management System (QMS), conducting internal audits, and managing external inspections. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, quality control, and regulatory affairs. As a remote specialist, you will be highly organized, detail-oriented, and adept at managing complex documentation and remote collaborations. Your responsibilities will include reviewing and approving batch records, deviation reports, change controls, and validation protocols. You will also lead investigations into quality issues, identify root causes, and implement corrective and preventive actions (CAPAs). Furthermore, you will train and mentor QA team members and liaise with cross-functional departments to foster a strong quality culture. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field is required, along with a minimum of 7 years of experience in pharmaceutical quality assurance. Extensive knowledge of regulatory requirements and experience with GxP environments are essential. Strong analytical, problem-solving, and leadership skills are crucial for success in this role. This is an excellent opportunity to contribute significantly to pharmaceutical quality and compliance from a remote setting. The original target location for this role was Nairobi, Nairobi, KE , but the position is entirely remote.
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Lead Remote Pharmaceutical Quality Assurance Specialist

40100 Kisumu KES100000 Annually WhatJobs Direct

Posted 2 days ago

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Job Description

full-time
Our client is seeking a highly motivated and experienced Lead Remote Pharmaceutical Quality Assurance Specialist to ensure the highest standards of quality and compliance within their operations. This is a fully remote position, requiring a deep understanding of pharmaceutical regulations, Good Manufacturing Practices (GMP), and quality management systems. You will be responsible for developing, implementing, and maintaining robust quality assurance protocols across all relevant stages of drug development and manufacturing. Your expertise will be critical in conducting remote audits, reviewing documentation, and providing guidance on quality-related issues. The ideal candidate will possess a strong background in pharmaceutical sciences, extensive experience in QA/QC, and a proven ability to interpret and apply complex regulatory guidelines (e.g., FDA, EMA). Proficiency in quality management software and advanced virtual communication tools is essential for effective collaboration with internal teams and external partners. Responsibilities include identifying potential compliance risks, developing corrective and preventive actions (CAPA), and contributing to continuous improvement initiatives. We are looking for an individual with exceptional analytical skills, meticulous attention to detail, and the ability to communicate complex technical information clearly and concisely. The capacity to lead virtual QA teams and drive a culture of quality and compliance in a remote setting is crucial. This is a significant opportunity to contribute to patient safety and the integrity of pharmaceutical products by applying your expertise from anywhere. Join our client's dedicated team and play a pivotal role in shaping the future of pharmaceutical quality assurance. The candidate must be proactive in staying updated with evolving regulatory landscapes and industry best practices.
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Principal Pharmaceutical Quality Assurance Specialist (Remote)

90110 Abothuguchi West KES480000 Annually WhatJobs Direct

Posted 2 days ago

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Job Description

full-time
Our client is seeking a highly experienced and meticulous Principal Pharmaceutical Quality Assurance Specialist to join their elite, fully remote team. This critical role will be instrumental in upholding and enhancing the company's commitment to pharmaceutical quality and regulatory compliance. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS) that adhere to global regulatory standards, including GMP, ICH, and FDA guidelines. Your expertise will be vital in conducting internal and external audits, reviewing batch records, investigating deviations and CAPAs (Corrective and Preventive Actions), and ensuring the integrity of pharmaceutical products throughout their lifecycle. This position demands a deep understanding of pharmaceutical manufacturing processes, analytical testing, validation protocols, and risk management principles. You will work closely with R&D, manufacturing, regulatory affairs, and other departments to ensure that all quality-related activities are executed with precision and efficiency. As a remote-first specialist, you must possess exceptional analytical and problem-solving skills, coupled with outstanding written and verbal communication abilities to effectively collaborate with global teams and stakeholders. The ability to interpret complex regulatory documents, conduct thorough risk assessments, and drive continuous improvement initiatives is paramount. We are looking for a proactive, detail-oriented individual with a proven track record in pharmaceutical quality assurance, preferably with experience in sterile products, biologics, or complex drug formulations. You will lead quality-focused projects, mentor junior QA personnel, and contribute significantly to the overall quality culture of the organization. This is a remote role requiring significant autonomy and strong organizational skills. The job location for reference, although this position is fully remote, is **Mlolongo, Machakos, KE**.
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