6,554 Senior Pharmaceutical Quality Assurance Analyst jobs in Kenya
Pharmaceutical Quality Assurance Specialist
Posted 22 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a meticulous and experienced Pharmaceutical Quality Assurance Specialist to join their team based in **Nyeri, Nyeri, KE**. This hybrid role requires a professional who can balance on-site responsibilities with remote work flexibility. You will be instrumental in ensuring that all pharmaceutical products meet rigorous quality standards and comply with regulatory requirements. Your primary responsibilities will include developing, implementing, and maintaining quality assurance systems, conducting internal audits, reviewing batch records, and investigating deviations and non-conformances. You will work closely with manufacturing, R&D, and regulatory affairs departments to ensure product integrity throughout its lifecycle. The ideal candidate will possess a strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant international regulatory guidelines. Excellent analytical, problem-solving, and documentation skills are essential. You must be proficient in quality management software and possess a keen eye for detail. This role demands a high level of integrity and a commitment to upholding the highest ethical standards in pharmaceutical quality. You will be involved in risk assessments, process validation, and continuous improvement initiatives. The ability to interpret complex technical data and translate it into actionable quality improvements is crucial. You will also play a role in training personnel on quality procedures and ensuring adherence to company policies. This position offers a fantastic opportunity to contribute to the development and manufacturing of life-saving medications within a respected organization. A strong scientific background, coupled with practical experience in a QA/QC environment, is highly desirable. The hybrid nature of this role allows for focused work at home, interspersed with essential on-site activities critical for quality oversight.
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Lead Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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Job Description
Our client is seeking a highly experienced and detail-oriented Lead Pharmaceutical Quality Assurance Specialist to ensure the highest standards of compliance and product integrity within their fully remote operations. This critical role involves developing, implementing, and maintaining robust quality management systems in accordance with global regulatory standards. The ideal candidate will possess deep expertise in pharmaceutical manufacturing processes, regulatory affairs, and quality control methodologies. You will lead quality initiatives, conduct audits, and drive continuous improvement, all from a remote work setting. This is a remote-first position, offering a significant opportunity for impact from anywhere in Kenya.
Responsibilities:
Responsibilities:
- Develop, implement, and manage comprehensive Quality Assurance (QA) programs for pharmaceutical products and processes.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory guidelines (e.g., FDA, EMA).
- Conduct internal and external audits of manufacturing sites, suppliers, and contract manufacturers.
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Investigate deviations, out-of-specifications (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Develop and maintain the company's Quality Management System (QMS), including SOPs, work instructions, and quality agreements.
- Provide training to personnel on QA principles, GMP, and regulatory requirements.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle.
- Manage the release of finished pharmaceutical products.
- Stay current with evolving regulatory landscapes and industry best practices.
- Lead quality improvement initiatives and contribute to the continuous enhancement of quality systems.
- Prepare for and host regulatory inspections.
- Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related scientific field.
- A minimum of 8 years of experience in Pharmaceutical Quality Assurance and Quality Control, with a strong focus on GMP compliance.
- In-depth knowledge of pharmaceutical manufacturing processes, analytical testing, and stability studies.
- Proven experience in conducting audits and managing CAPA systems.
- Familiarity with global regulatory requirements and submission processes.
- Excellent understanding of quality risk management principles.
- Strong analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly and concisely.
- Demonstrated leadership capabilities and the ability to manage projects and teams remotely.
- Proficiency in using quality management software and standard office applications.
- Relevant professional certifications (e.g., ASQ CQA) are a plus.
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Senior Pharmaceutical Quality Assurance Analyst
Posted 7 days ago
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Job Description
Our client, a leader in the pharmaceutical industry, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Analyst to join their team in Kakamega, Kakamega, KE . This critical role involves ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements. You will be responsible for developing, implementing, and maintaining quality assurance systems and procedures throughout the manufacturing process, from raw material inspection to finished product release. Key duties include conducting thorough investigations of deviations and out-of-specification results, implementing corrective and preventive actions (CAPAs), and participating in internal and external audits. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines (e.g., FDA, EMA). You will play a vital role in process validation, equipment qualification, and stability testing. Collaborating closely with R&D, production, and regulatory affairs departments will be essential to ensure seamless quality control. This position requires exceptional analytical and problem-solving skills, meticulous attention to detail, and strong documentation abilities. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field is required, along with a minimum of 5 years of experience in pharmaceutical quality assurance. Strong leadership potential and the ability to mentor junior team members are also highly valued. This role demands a proactive approach to quality management and a commitment to upholding the highest standards of product safety and efficacy. You will be instrumental in driving continuous improvement within the quality assurance framework and ensuring compliance with all applicable regulations. The successful candidate will demonstrate excellent communication skills and the ability to work effectively within a team environment. This is a challenging yet rewarding opportunity to contribute to the development and production of life-saving medicines.
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2
Remote Pharmaceutical Quality Assurance Analyst
Posted 22 days ago
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Job Description
Our client is seeking a highly detail-oriented and knowledgeable Remote Pharmaceutical Quality Assurance Analyst to ensure adherence to regulatory standards and best practices in pharmaceutical manufacturing and development. This fully remote role requires a thorough understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory guidelines relevant to the pharmaceutical industry. You will be responsible for reviewing and analyzing quality data, batch records, validation reports, and audit findings to ensure product quality, safety, and efficacy. The ideal candidate possesses strong analytical skills, excellent documentation abilities, and a meticulous approach to quality control. You will remotely collaborate with manufacturing sites, R&D teams, and regulatory affairs departments to identify and resolve quality issues, implement corrective and preventive actions (CAPAs), and drive continuous improvement initiatives. This position demands a deep understanding of pharmaceutical processes, analytical methods, and quality management systems. You will play a critical role in maintaining compliance with international regulatory requirements (e.g., FDA, EMA). If you are a dedicated QA professional with a passion for ensuring pharmaceutical product integrity and excel in a remote work environment, we encourage you to apply. While remote, this role supports quality assurance operations that may impact pharmaceutical products distributed or manufactured with connections to the **Nairobi, Nairobi, KE** hub and its pharmaceutical ecosystem.
Key Responsibilities:
Key Responsibilities:
- Review and approve batch records, analytical data, and validation reports.
- Investigate deviations, out-of-specifications (OOS), and customer complaints.
- Develop and implement Corrective and Preventive Actions (CAPAs).
- Ensure compliance with GMP, GLP, and other relevant regulatory guidelines.
- Participate in internal and external audits as a remote representative.
- Contribute to the development and maintenance of Quality Management Systems (QMS).
- Perform risk assessments related to product quality and regulatory compliance.
- Monitor key quality indicators and prepare quality performance reports.
- Collaborate with cross-functional teams to resolve quality-related issues.
- Stay updated on pharmaceutical regulations and quality standards.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Proven experience in Pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of GMP, GLP, and relevant pharmaceutical regulations.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent documentation and technical writing abilities.
- Experience with QMS and CAPA systems.
- Ability to work independently and manage multiple tasks in a remote setting.
- Proficiency with common pharmaceutical industry software and data analysis tools.
- Strong communication and interpersonal skills for remote collaboration.
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3
Principal Pharmaceutical Quality Assurance Specialist
Posted 7 days ago
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Job Description
Our client, a reputable pharmaceutical manufacturer, is seeking a highly accomplished Principal Pharmaceutical Quality Assurance Specialist to enhance their quality management systems. This is a crucial, fully remote position, allowing an expert to drive quality initiatives across the organization without geographical constraints. The successful candidate will be responsible for developing, implementing, and maintaining robust quality assurance programs, ensuring compliance with all relevant regulatory standards, including GMP, GDP, and ICH guidelines. You will lead audits, manage deviations and CAPAs, and oversee change control processes to uphold the highest quality standards.
This role demands a meticulous attention to detail, a comprehensive understanding of pharmaceutical manufacturing processes, and a strong command of quality control principles. You will be instrumental in conducting internal and external audits, supplier quality management, and risk assessments. The Principal Pharmaceutical Quality Assurance Specialist will also be responsible for training personnel on quality systems and procedures, fostering a culture of quality throughout the organization. You will analyze quality data, identify trends, and propose continuous improvement initiatives to enhance product safety and efficacy. The ability to interpret complex regulatory requirements, implement effective quality solutions, and lead cross-functional teams in a remote setting is essential. This is an excellent opportunity for a seasoned QA professional to make a significant impact on product quality and regulatory compliance.
Responsibilities:
This role demands a meticulous attention to detail, a comprehensive understanding of pharmaceutical manufacturing processes, and a strong command of quality control principles. You will be instrumental in conducting internal and external audits, supplier quality management, and risk assessments. The Principal Pharmaceutical Quality Assurance Specialist will also be responsible for training personnel on quality systems and procedures, fostering a culture of quality throughout the organization. You will analyze quality data, identify trends, and propose continuous improvement initiatives to enhance product safety and efficacy. The ability to interpret complex regulatory requirements, implement effective quality solutions, and lead cross-functional teams in a remote setting is essential. This is an excellent opportunity for a seasoned QA professional to make a significant impact on product quality and regulatory compliance.
Responsibilities:
- Develop and maintain pharmaceutical quality assurance systems and SOPs.
- Ensure compliance with GMP, GDP, and other relevant pharmaceutical regulations.
- Lead internal and external audits, including supplier audits.
- Manage deviation investigations, CAPA implementation, and change control processes.
- Analyze quality data, identify trends, and implement corrective and preventive actions.
- Oversee risk management activities related to product quality.
- Train staff on quality assurance procedures and regulatory requirements.
- Collaborate with manufacturing, R&D, and regulatory affairs teams.
- Champion a strong quality culture throughout the organization.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Advanced degree or relevant certifications (e.g., ASQ CQA) are a plus.
- Minimum of 10 years of experience in pharmaceutical quality assurance.
- In-depth knowledge of GMP, GDP, ICH guidelines, and regulatory submission processes.
- Proven experience in conducting audits, managing deviations, and implementing CAPAs.
- Strong analytical and problem-solving skills.
- Excellent leadership, communication, and interpersonal skills.
- Ability to interpret complex regulatory requirements and drive compliance.
- Experience leading quality initiatives in a remote environment.
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4
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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Job Description
Our client is seeking a meticulous and experienced Senior Pharmaceutical Quality Assurance Specialist to join our fully remote Quality team. This role is critical in ensuring that our pharmaceutical products meet the highest standards of quality, safety, and efficacy, in compliance with regulatory requirements. You will be responsible for developing, implementing, and maintaining quality systems, conducting internal audits, reviewing documentation, and investigating deviations. This is a remote-first position, requiring a highly organized and self-motivated professional with a deep understanding of GMP (Good Manufacturing Practices) and regulatory guidelines. Your responsibilities will include overseeing batch record reviews, managing change control processes, participating in regulatory inspections, performing risk assessments, and ensuring the continuous improvement of quality processes. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments, all managed through effective remote communication. The ideal candidate will possess a strong scientific background, excellent analytical and problem-solving skills, and a keen eye for detail. Proven experience in pharmaceutical quality assurance and a thorough knowledge of regulatory frameworks are essential. Strong written and verbal communication skills are vital for effective remote collaboration and documentation.
Key Qualifications:
Key Qualifications:
- Bachelor's or Master'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 regulations (e.g., FDA, EMA) and quality management systems.
- Proven experience in batch record review, deviation investigation, and CAPA management.
- Experience with internal and external audits, including preparation for regulatory inspections.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent analytical, problem-solving, and critical thinking skills.
- Demonstrated ability to work independently and manage time effectively in a remote setting.
- Exceptional attention to detail and commitment to accuracy.
- Strong written and verbal communication skills.
- Familiarity with quality risk management principles.
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5
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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Job Description
Our client, a prominent player in the Pharmaceutical industry, is seeking a meticulous and experienced Remote Pharmaceutical Quality Assurance Specialist. This fully remote position is essential for ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements. You will be responsible for developing, implementing, and maintaining quality management systems (QMS) that comply with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines. Your duties will include reviewing batch records, investigating deviations and out-of-specification (OOS) results, and implementing corrective and preventive actions (CAPA). The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, quality control principles, and regulatory affairs. Proficiency in quality management software, statistical analysis, and document control systems is crucial. You will collaborate with cross-functional teams, including manufacturing, research and development, and regulatory affairs, to ensure product quality and compliance. This role demands excellent attention to detail, strong analytical skills, and the ability to make sound judgments regarding product quality. The ability to work independently, manage documentation efficiently, and communicate complex quality issues clearly and concisely is essential. This is a significant opportunity to contribute to the safety and efficacy of pharmaceutical products while enjoying the flexibility of remote work. You will play a vital role in upholding the integrity and reputation of our client. A commitment to continuous improvement and a thorough understanding of the pharmaceutical regulatory landscape are paramount. The **location** for this role is conceptually tied to Garissa, Garissa, KE , but the position itself is fully remote, allowing you to work from anywhere.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain Quality Management Systems (QMS).
- Ensure compliance with GMP, GLP, and other relevant pharmaceutical regulations.
- Review and approve batch manufacturing records and associated documentation.
- Investigate deviations, OOS results, and customer complaints, implementing CAPA plans.
- Conduct internal audits and support external regulatory inspections.
- Collaborate with R&D, manufacturing, and regulatory affairs teams on quality-related matters.
- Develop and deliver training programs on quality standards and procedures.
- Monitor and analyze quality metrics to identify trends and areas for improvement.
- Participate in supplier qualification and quality agreements.
- Maintain accurate and organized quality records.
- Bachelor's or Master'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, GLP, ICH guidelines, and other relevant regulatory standards.
- Experience with QMS, CAPA, deviation management, and change control processes.
- Proficiency in quality management software and statistical analysis tools.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent documentation and communication skills.
- Ability to work independently, manage priorities, and meet deadlines in a remote environment.
- Detail-oriented with a strong commitment to quality and compliance.
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6
Pharmaceutical Quality Assurance Specialist (Remote)
Posted 4 days ago
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Job Description
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:
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.
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7
Lead Remote Pharmaceutical Quality Assurance Specialist
Posted 7 days ago
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Job Description
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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8
Pharmaceutical Quality Assurance Analyst
Posted 1 day ago
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Job Description
Our client is seeking a meticulous and detail-oriented Pharmaceutical Quality Assurance Analyst to join their team. This role involves a hybrid work arrangement, requiring a combination of remote work and on-site presence at our facilities located in **Kakamega, Kakamega, KE**. The successful candidate will play a critical role in ensuring that our pharmaceutical products meet the highest standards of quality, safety, and efficacy. Responsibilities include developing, implementing, and maintaining quality assurance systems and procedures, conducting internal audits, reviewing batch records, investigating deviations and out-of-specification results, and preparing quality reports. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments to ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines. The ability to analyze data, identify trends, and implement corrective and preventive actions (CAPA) is crucial. Strong understanding of pharmaceutical manufacturing processes and quality control principles is essential. Excellent written and verbal communication skills are required, as is proficiency in using quality management software and standard office applications. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field is mandatory. A Master's degree or relevant professional certifications (e.g., ASQ CQE) are a plus. Previous experience in pharmaceutical quality assurance or quality control is highly desirable. The ideal candidate is proactive, analytical, and committed to upholding the highest standards of pharmaceutical quality. This hybrid model allows for flexibility while ensuring essential hands-on involvement and team collaboration necessary for maintaining stringent quality benchmarks. Our client values rigorous adherence to protocols and fosters an environment of continuous improvement in all aspects of drug development and manufacturing. The insights gained from on-site work will complement remote analysis, creating a robust QA framework. You will be instrumental in ensuring the integrity and reliability of our client's product portfolio.
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