85 Senior Pharmaceutical Quality Assurance Specialist jobs in whatjobs

Senior Pharmaceutical Quality Assurance Specialist

00200 Ngong KES95000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a dedicated Senior Pharmaceutical Quality Assurance Specialist to join their esteemed team in **Ruiru, Kiambu, KE**. This role is critical in ensuring the highest standards of quality and compliance are maintained throughout the pharmaceutical manufacturing process. The successful candidate will play a vital role in developing, implementing, and maintaining robust quality systems and procedures in accordance with international regulatory guidelines (e.g., GMP, ICH). You will be responsible for conducting internal and external audits, reviewing and approving batch records, deviations, change controls, and CAPAs. A key aspect of this position involves collaborating closely with various departments, including manufacturing, R&D, and regulatory affairs, to identify potential quality risks and implement effective mitigation strategies. You will also be involved in the validation of equipment, processes, and analytical methods, ensuring all activities meet stringent regulatory requirements. The Senior QA Specialist will contribute to regulatory submissions by providing accurate quality documentation and responding to queries from health authorities. Furthermore, you will train and mentor junior QA personnel, fostering a culture of quality awareness and continuous improvement within the organization. This role requires a thorough understanding of pharmaceutical science, manufacturing operations, and quality management principles. The ideal candidate will possess excellent analytical and problem-solving skills, meticulous attention to detail, and exceptional written and verbal communication abilities. A strong ability to interpret complex regulatory documents and apply them to practical scenarios is essential. This is an exciting opportunity to contribute to the development and production of life-saving medicines while working within a dynamic and forward-thinking company. The successful applicant will have the chance to shape quality strategies and make a tangible difference in patient safety and product efficacy. Strong interpersonal skills are necessary for effective cross-functional collaboration.
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Senior Pharmaceutical Quality Assurance Specialist

01000 Makongeni KES155000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client is seeking a meticulous and experienced Senior Pharmaceutical Quality Assurance Specialist to uphold the highest standards of quality and compliance within their operations. This is a fully remote position, allowing you to contribute to global pharmaceutical quality systems from your home office. The specialist will be responsible for developing, implementing, and maintaining robust quality assurance programs, ensuring adherence to regulatory requirements and industry best practices. You will play a pivotal role in safeguarding product integrity and patient safety.

Key responsibilities include:
  • Developing, implementing, and maintaining Quality Management Systems (QMS) in accordance with cGMP, ICH, and other relevant guidelines.
  • Conducting internal audits and supporting external regulatory inspections (e.g., FDA, EMA).
  • Reviewing and approving batch records, validation protocols, and deviation reports.
  • Managing change control processes and ensuring proper documentation.
  • Investigating quality incidents, deviations, and customer complaints, and implementing corrective and preventive actions (CAPAs).
  • Overseeing vendor qualification and quality agreements.
  • Participating in product quality reviews and risk assessments.
  • Providing training to personnel on quality assurance principles and procedures.
  • Staying up-to-date with evolving regulatory requirements and industry best practices.
  • Collaborating with manufacturing, R&D, and regulatory affairs teams to ensure seamless quality oversight.

The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. A minimum of 5 years of experience in pharmaceutical quality assurance or quality control is required. Deep understanding of cGMP, GCP, and GLP principles is essential. Experience with regulatory inspections and audits is highly desirable. Strong analytical, problem-solving, and decision-making skills are critical for effective quality oversight. Excellent written and verbal communication skills are necessary for documentation and interdepartmental collaboration. The ability to work independently, manage multiple responsibilities, and maintain a high level of accuracy in a remote setting is paramount. Join our client in ensuring the safety and efficacy of pharmaceutical products, contributing to patient health for markets including Thika, Kiambu, KE .
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Senior Pharmaceutical Quality Assurance Specialist

20200 Kapsuser KES280000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a dynamic pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their remote team. This critical role ensures adherence to stringent regulatory standards and quality management systems throughout the pharmaceutical lifecycle. You will be responsible for developing, implementing, and maintaining robust quality assurance programs, conducting internal audits, reviewing documentation, and investigating deviations and out-of-specification results. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant international regulatory guidelines (e.g., FDA, EMA). Strong analytical, problem-solving, and communication skills are essential, along with meticulous attention to detail. You will collaborate closely with R&D, manufacturing, regulatory affairs, and other departments through virtual platforms to ensure product quality and compliance. This position offers the flexibility of remote work, allowing you to contribute to ensuring the highest standards of pharmaceutical quality from your home office. You will play a pivotal role in safeguarding product integrity, patient safety, and regulatory compliance. Experience with quality risk management, change control, and validation processes is highly valued. This is a senior position requiring a proactive approach to identifying and addressing quality issues and driving continuous improvement in quality systems. Our client is dedicated to innovation and patient well-being, and this role is key to upholding those commitments.

Key Responsibilities:
  • Develop, implement, and maintain Quality Assurance (QA) systems and procedures.
  • Ensure compliance with cGMP, GLP, and other relevant regulatory standards.
  • Conduct internal audits and inspections of manufacturing and laboratory operations.
  • Review and approve batch records, validation documents, and change controls.
  • Investigate deviations, CAPAs (Corrective and Preventive Actions), and out-of-specification (OOS) results.
  • Participate in regulatory inspections and support external audits.
  • Develop and deliver quality training programs to relevant personnel.
  • Monitor and assess quality trends and recommend improvements.
  • Collaborate with cross-functional teams to resolve quality issues.
  • Stay current with evolving pharmaceutical regulations and industry best practices.

This is a fully remote position, providing excellent flexibility for qualified candidates. The operational scope covers pharmaceutical quality assurance for activities relevant to Kericho, Kericho, KE , and its broader market.
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Senior Pharmaceutical Quality Assurance Specialist

10100 Nyeri Town KES180000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a leading name in pharmaceutical innovation, is seeking a highly motivated and experienced Senior Pharmaceutical Quality Assurance Specialist to join their dynamic, fully remote team. This pivotal role will be instrumental in ensuring the highest standards of quality and compliance across all pharmaceutical development and manufacturing processes. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory requirements. You will be responsible for developing, implementing, and maintaining quality systems, conducting internal and external audits, reviewing batch records, investigating deviations and out-of-specification results, and contributing to regulatory submissions. This is a unique opportunity to make a significant impact from the comfort of your home office, collaborating with cross-functional teams globally. The role demands meticulous attention to detail, strong analytical and problem-solving skills, and the ability to communicate complex technical information effectively. Your expertise will directly contribute to the safety, efficacy, and quality of life-saving medications. We are looking for an individual who is proactive, adaptable, and thrives in a remote-first environment, demonstrating excellent self-management and time management skills. The chosen candidate will also play a key role in training and mentoring junior QA personnel, fostering a culture of continuous improvement. Your responsibilities will extend to managing change control processes, ensuring all documentation is accurate and up-to-date, and staying abreast of evolving industry trends and regulations. The successful applicant will be a collaborative team player with a strong ethical compass and a commitment to upholding the highest standards in the pharmaceutical industry. This position offers a competitive salary and benefits package, alongside the flexibility and autonomy of a remote role, supporting professional growth and work-life balance. Join us in shaping the future of pharmaceuticals.
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Senior Pharmaceutical Quality Assurance Specialist

70100 Abothuguchi West KES170000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a distinguished pharmaceutical company committed to advancing healthcare, is seeking an experienced Senior Pharmaceutical Quality Assurance Specialist to join their esteemed, fully remote team. This critical role will ensure adherence to the highest standards of quality and regulatory compliance throughout the pharmaceutical product lifecycle. You will be responsible for developing, implementing, and maintaining robust quality management systems, conducting internal and external audits, and ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulatory guidelines. This position requires meticulous attention to detail, a deep understanding of pharmaceutical processes, and a strong commitment to product safety and efficacy. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments to uphold quality standards.

Key Responsibilities:
  • Develop, implement, and maintain the Quality Management System (QMS) in compliance with regulatory requirements.
  • Conduct internal audits of various departments and processes to ensure adherence to GMP, GCP, and other standards.
  • Participate in external audits by regulatory agencies and customers.
  • Review and approve batch records, validation protocols, and other quality-related documentation.
  • Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
  • Manage change control processes and risk assessments.
  • Provide training to personnel on quality assurance procedures and regulatory requirements.
  • Monitor industry trends and regulatory updates to ensure ongoing compliance.
  • Collaborate with cross-functional teams to resolve quality issues and drive continuous improvement.
  • Maintain accurate and organized quality records.

Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A Master's degree is preferred.
  • Minimum of 6 years of experience in pharmaceutical quality assurance or quality control.
  • In-depth knowledge of GMP, GCP, ICH guidelines, and other relevant pharmaceutical regulations.
  • Experience with auditing processes and performing quality risk assessments.
  • Strong understanding of pharmaceutical manufacturing processes and analytical testing.
  • Excellent analytical, problem-solving, and documentation skills.
  • Effective communication and interpersonal skills, with the ability to collaborate across departments.
  • Proficiency in quality management software and MS Office Suite.
  • Ability to work independently and manage time effectively in a remote environment.

This is an exceptional opportunity for a dedicated QA professional to contribute to a leading pharmaceutical organization while enjoying the flexibility of a fully remote role. Our client values expertise and provides a supportive remote work culture. If you are passionate about ensuring the quality and safety of life-saving medicines, apply today. This role, though remote, is associated with the regulatory environment of **Garissa, Garissa, KE**.
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Senior Pharmaceutical Quality Assurance Specialist

60200 Meru , Eastern KES160000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a leading pharmaceutical innovator, is seeking a highly meticulous and experienced Senior Pharmaceutical Quality Assurance Specialist to join their dynamic, fully remote Quality team. This pivotal role offers the exciting opportunity to contribute to ensuring the highest standards of quality and compliance in drug development and manufacturing, working from your preferred location, including **Meru, Meru, KE**. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS), conducting internal audits, ensuring adherence to Good Manufacturing Practices (GMP), and supporting regulatory inspections. Your deep understanding of pharmaceutical regulations, quality control processes, and documentation best practices will be essential. This position requires exceptional attention to detail, analytical skills, and the ability to collaborate effectively within a distributed team environment.

Responsibilities:
  • Develop, implement, and maintain the Quality Management System (QMS) in accordance with relevant pharmaceutical regulations (e.g., GMP, ICH guidelines).
  • Conduct internal audits and assessments of manufacturing processes, documentation, and facilities to ensure compliance.
  • Review and approve critical quality-related documents, including batch records, validation protocols, and SOPs.
  • Manage and oversee deviation investigations, CAPA (Corrective and Preventive Actions) implementation, and change control processes.
  • Support external regulatory inspections and client audits, ensuring preparedness and successful outcomes.
  • Provide training to personnel on GMP requirements, quality procedures, and best practices.
  • Monitor and analyze quality metrics, identifying trends and recommending proactive measures to prevent quality issues.
  • Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality is integrated throughout the product lifecycle.
  • Stay current with evolving pharmaceutical regulations and industry standards.
  • Contribute to the continuous improvement of quality processes and systems.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related life science field.
  • Minimum of 7 years of experience in pharmaceutical quality assurance or quality control, with a strong understanding of GMP regulations.
  • Proven experience in developing and managing QMS, conducting audits, and handling regulatory inspections.
  • In-depth knowledge of pharmaceutical manufacturing processes and analytical testing methods.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Strong documentation and technical writing abilities.
  • Exceptional attention to detail and commitment to accuracy.
  • Effective communication and interpersonal skills for remote collaboration.
  • Proficiency in using quality management software and tools.
This is a fully remote position, allowing you to work from **Meru, Meru, KE**, or your chosen remote location. If you are a dedicated Quality Assurance professional passionate about ensuring the highest standards in the pharmaceutical industry, we encourage you to apply.
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Senior Pharmaceutical Quality Assurance Specialist

70100 Abothuguchi West KES115000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a rapidly growing pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their dedicated remote team. This crucial role involves ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, adhering strictly to regulatory guidelines such as cGMP, FDA, and EMA requirements. You will be responsible for developing, implementing, and maintaining robust quality management systems, conducting internal and external audits, and overseeing all aspects of quality control throughout the product lifecycle. As a fully remote position, you will collaborate extensively with research and development, manufacturing, and regulatory affairs departments to ensure compliance and drive continuous improvement. The ideal candidate possesses a meticulous attention to detail, strong analytical skills, and a comprehensive understanding of pharmaceutical manufacturing processes and quality standards. This is an exceptional opportunity to make a significant impact on patient safety and product integrity within a dynamic, remote-first organization.

Key Responsibilities:
  • Develop, implement, and maintain a comprehensive Quality Management System (QMS) in compliance with cGMP and other relevant regulations.
  • Conduct internal audits of manufacturing processes, facilities, and documentation to ensure compliance.
  • Participate in external audits and inspections by regulatory agencies (e.g., FDA, EMA).
  • Review and approve batch records, validation protocols, and other critical quality documentation.
  • Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
  • Monitor and analyze quality metrics, identifying trends and recommending improvements to quality processes.
  • Manage change control processes for products, processes, and equipment.
  • Train personnel on quality assurance procedures, cGMP principles, and regulatory requirements.
  • Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure quality is integrated throughout the product lifecycle.
  • Evaluate and approve raw material suppliers and contract manufacturers.
  • Stay current with evolving pharmaceutical regulations and industry best practices.
  • Lead and mentor junior QA team members.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
  • In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.).
  • Proven experience in developing and implementing QMS, conducting audits, and managing CAPAs.
  • Strong understanding of pharmaceutical manufacturing processes and product development.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Meticulous attention to detail and a commitment to accuracy.
  • Exceptional written and verbal communication skills.
  • Ability to work independently and collaboratively in a remote team environment.
  • Experience with quality control testing and instrumentation is a plus.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Quality Assurance Specialist

40200 Abothuguchi West KES260000 Annually WhatJobs

Posted 20 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 esteemed team in a completely remote capacity. This critical role will be responsible for upholding the highest standards of quality and compliance throughout the pharmaceutical product lifecycle. You will play a key role in developing, implementing, and maintaining robust quality management systems (QMS) in line with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory requirements. Your responsibilities will include conducting internal audits, reviewing batch records, investigating deviations and Out-of-Specification (OOS) results, and managing corrective and preventive actions (CAPA). The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control methodologies. You will collaborate closely with R&D, manufacturing, and regulatory departments to ensure product integrity and patient safety. This is an outstanding opportunity for a dedicated QA professional to contribute to a vital industry while enjoying the flexibility of a remote-first role, working from anywhere in Kenya. We are looking for an individual with exceptional analytical skills, meticulous attention to detail, and strong problem-solving capabilities. The ability to interpret complex regulatory guidelines, manage multiple projects, and communicate effectively with diverse teams in a virtual setting is paramount. Your expertise will support the quality assurance of products that may eventually serve markets near Garissa, Garissa, KE , however, your professional workspace will be fully remote.

Key Responsibilities:
  • Develop, implement, and maintain the Quality Management System (QMS) for pharmaceutical operations.
  • Ensure compliance with GMP, GDP, and other applicable regulatory guidelines (e.g., FDA, EMA).
  • Conduct internal audits and support external regulatory inspections.
  • Review and approve batch manufacturing records, analytical test results, and stability data.
  • Investigate deviations, OOS results, and customer complaints, implementing CAPA.
  • Manage change control processes to assess and implement changes to processes, materials, or equipment.
  • Participate in supplier qualification and audits.
  • Provide QA oversight for product development and lifecycle management.
  • Train personnel on quality assurance procedures and regulatory requirements.
  • Prepare and review quality-related documentation, including SOPs, policies, and validation protocols.
  • Monitor regulatory intelligence and ensure the QMS remains up-to-date.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 6 years of progressive experience in Pharmaceutical Quality Assurance or Quality Control.
  • Extensive knowledge of GMP, GDP, and other relevant pharmaceutical regulations.
  • Proven experience in auditing, deviation management, and CAPA implementation.
  • Familiarity with pharmaceutical manufacturing processes and analytical testing.
  • Excellent written and verbal communication skills, with the ability to document complex information clearly.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Proficiency in quality management software and standard office applications.
  • Ability to work independently, manage multiple priorities, and meet deadlines in a remote environment.
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Senior Pharmaceutical Quality Assurance Specialist

30200 Tuwan KES180000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client is seeking a meticulous and experienced Senior Pharmaceutical Quality Assurance Specialist to lead and enhance their quality management systems. This is a fully remote position, offering the flexibility to work from anywhere while making a significant impact. You will be responsible for ensuring that all pharmaceutical products meet rigorous quality standards and comply with regulatory requirements (e.g., cGMP, FDA, WHO). Your role will involve developing, implementing, and maintaining quality assurance protocols, conducting internal audits, reviewing batch records, and managing deviation and CAPA processes. The ideal candidate will possess a strong understanding of pharmaceutical manufacturing processes, analytical testing, and regulatory affairs. You will collaborate closely with R&D, production, and regulatory departments to ensure product integrity throughout the lifecycle. This position requires exceptional attention to detail, strong analytical and problem-solving skills, and the ability to interpret complex regulatory guidelines. You will also play a key role in training QA personnel and contributing to the continuous improvement of quality systems. The ability to work independently, manage time effectively, and communicate complex quality-related information clearly is paramount in this remote role. This is an excellent opportunity to advance your career in pharmaceutical quality assurance with a leading organization.

Responsibilities:
  • Develop, implement, and maintain robust Quality Assurance (QA) systems and procedures.
  • Conduct internal audits and inspections to ensure compliance with cGMP and other relevant regulations.
  • Review and approve batch records, analytical data, and validation reports.
  • Manage deviation investigations, root cause analysis, and Corrective and Preventive Actions (CAPA).
  • Oversee the qualification and validation of equipment and processes.
  • Collaborate with R&D and Production teams to ensure product quality from development to commercialization.
  • Prepare for and participate in regulatory inspections (e.g., FDA, EMA).
  • Stay current with evolving regulatory requirements and industry best practices.
  • Develop and deliver QA training programs for relevant personnel.
  • Contribute to the continuous improvement of quality processes and overall compliance.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. Master's degree preferred.
  • Minimum of 7 years of experience in Pharmaceutical Quality Assurance/Quality Control.
  • In-depth knowledge of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
  • Experience with regulatory submissions and inspections.
  • Proficiency in quality management software and tools.
  • Strong analytical, problem-solving, and decision-making skills.
  • Excellent documentation and communication abilities, both written and verbal.
  • Proven ability to work independently and manage multiple projects in a remote environment.
  • Experience in sterile manufacturing or biologics is a plus.
  • Strong understanding of risk management principles.
The role is located in **Eldoret, Uasin Gishu, KE**, but is a fully remote position.
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Senior Pharmaceutical Quality Assurance Specialist

50200 Tuwan KES130000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a prominent entity in the pharmaceutical sector, is seeking a highly skilled and detail-oriented Senior Pharmaceutical Quality Assurance Specialist. This is a fully remote position, allowing you to contribute to vital quality initiatives from the convenience of your home office. The successful candidate will be responsible for ensuring that all pharmaceutical products and processes meet stringent regulatory standards and internal quality requirements. Your role will involve developing, implementing, and maintaining the company's Quality Management System (QMS) to ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulations.

Key responsibilities include conducting internal audits, overseeing external audits, and managing deviations and corrective/preventive actions (CAPAs). You will be instrumental in reviewing and approving batch records, validation protocols, and change controls. This position requires a thorough understanding of pharmaceutical manufacturing processes, quality control methodologies, and regulatory affairs. The ideal candidate will possess exceptional analytical skills, a meticulous approach to documentation, and the ability to identify potential quality risks and propose effective solutions. You will collaborate with various departments, including R&D, manufacturing, and regulatory affairs, to uphold the highest standards of quality.

Essential qualifications include a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is an advantage. A minimum of 7 years of progressive experience in pharmaceutical quality assurance or quality control is mandatory. In-depth knowledge of regulatory guidelines from bodies such as the FDA, EMA, and local Kenyan authorities is crucial. Experience with risk management principles and deviation investigations is required. Excellent written and verbal communication skills, strong problem-solving abilities, and proficiency in QMS software are essential. This is an excellent opportunity for a dedicated QA professional to drive quality excellence in the pharmaceutical industry from a remote setting, significantly contributing to patient safety and product integrity.
This advertiser has chosen not to accept applicants from your region.

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