1,969 Pharmaceutical Quality Assurance Specialist jobs in Kenya
Pharmaceutical Quality Assurance Specialist
Posted 21 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 21 days ago
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Job Description
Our client is seeking an accomplished Lead Pharmaceutical Quality Assurance Specialist to oversee and enhance their quality management systems, operating entirely remotely. This crucial role ensures that all pharmaceutical products and processes comply with stringent regulatory standards, internal policies, and customer requirements. You will be responsible for developing, implementing, and maintaining robust quality assurance programs, conducting thorough audits, and leading investigations into deviations and non-conformities. The ideal candidate will possess a strong background in pharmaceutical sciences, quality control, or a related field, with extensive experience in GMP (Good Manufacturing Practices) and regulatory compliance. Responsibilities include managing quality documentation, coordinating quality review boards, and collaborating with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to drive quality initiatives. You will also be responsible for training and mentoring junior QA staff, fostering a culture of quality excellence throughout the organization. This position demands exceptional analytical and problem-solving skills, meticulous attention to detail, and outstanding communication and interpersonal abilities to effectively influence and collaborate in a remote setting. You will play a pivotal role in ensuring the safety, efficacy, and integrity of our pharmaceutical products, thereby safeguarding patient health and maintaining the company's reputation. Experience with pharmaceutical quality systems software and a thorough understanding of global regulatory requirements (FDA, EMA, etc.) are essential. This is an unparalleled opportunity for a dedicated QA professional to lead significant quality assurance efforts, drive continuous improvement, and contribute to the development of life-saving medicines in a challenging and rewarding remote role. If you are passionate about pharmaceutical quality and possess the leadership expertise to excel, we encourage you to apply.
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Senior Pharmaceutical Quality Assurance Analyst
Posted 12 days ago
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Job Description
Our client is looking for a highly experienced Senior Pharmaceutical Quality Assurance Analyst to join their team. This role is integral to ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements. The analyst will be responsible for developing, implementing, and maintaining quality assurance systems and procedures throughout the product lifecycle, from raw material testing to finished product release. Key duties include conducting in-depth analysis of manufacturing processes, reviewing batch records, investigating deviations and out-of-specification (OOS) results, and implementing corrective and preventive actions (CAPA).
You will play a crucial role in preparing for and participating in internal and external audits, including regulatory inspections. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant pharmaceutical regulations (e.g., FDA, EMA). Strong analytical skills, meticulous attention to detail, and excellent problem-solving abilities are essential. You will be responsible for trend analysis of quality data, identifying potential risks, and recommending improvements to quality systems. Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, will be a significant aspect of the role. Excellent written and verbal communication skills are required for documenting findings and communicating with stakeholders. This position offers a hybrid work arrangement, combining remote flexibility with occasional on-site presence for critical activities. This is a challenging and rewarding opportunity to contribute to the safety and efficacy of pharmaceutical products within a leading organization.
Location Highlight: This role offers a hybrid work arrangement, with a primary focus on operations related to Bungoma, Bungoma, KE .
You will play a crucial role in preparing for and participating in internal and external audits, including regulatory inspections. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant pharmaceutical regulations (e.g., FDA, EMA). Strong analytical skills, meticulous attention to detail, and excellent problem-solving abilities are essential. You will be responsible for trend analysis of quality data, identifying potential risks, and recommending improvements to quality systems. Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, will be a significant aspect of the role. Excellent written and verbal communication skills are required for documenting findings and communicating with stakeholders. This position offers a hybrid work arrangement, combining remote flexibility with occasional on-site presence for critical activities. This is a challenging and rewarding opportunity to contribute to the safety and efficacy of pharmaceutical products within a leading organization.
Location Highlight: This role offers a hybrid work arrangement, with a primary focus on operations related to Bungoma, Bungoma, KE .
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Remote Pharmaceutical Quality Assurance Analyst
Posted 21 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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Principal Pharmaceutical Quality Assurance Specialist
Posted 11 days ago
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Job Description
Our client, a leading global pharmaceutical company, is seeking a highly experienced Principal Pharmaceutical Quality Assurance Specialist to join their esteemed remote team. This role is pivotal in ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, entirely managed through remote collaboration. You will be responsible for developing, implementing, and maintaining comprehensive quality management systems, including cGMP, GCP, and GLP compliance. Your duties will involve conducting internal audits, managing external audits, investigating deviations and CAPAs, and ensuring regulatory compliance with global health authorities. You will collaborate closely with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle. A significant part of your role will involve risk assessment, trend analysis of quality data, and continuous improvement initiatives to enhance product quality and process robustness. You will also be involved in the review and approval of documentation, including validation protocols, batch records, and change controls. This position requires a deep understanding of pharmaceutical manufacturing processes, analytical testing, and regulatory requirements. The ideal candidate will possess a Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field, with a minimum of 8 years of progressive experience in pharmaceutical quality assurance. Exceptional analytical, problem-solving, and critical thinking skills are essential. Strong knowledge of regulatory guidelines (FDA, EMA) and experience with electronic quality management systems (eQMS) are highly desirable. You must be adept at working independently, managing complex quality projects remotely, and fostering a strong quality culture across distributed teams. This is a remarkable opportunity to contribute significantly to patient safety and drug quality within a world-class pharmaceutical organization, operating entirely in a remote capacity.
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Senior Pharmaceutical Quality Assurance Specialist
Posted 21 days ago
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Job Description
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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Remote Pharmaceutical Quality Assurance Specialist
Posted 21 days ago
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Job Description
Our client, a dynamic pharmaceutical company, is seeking a meticulous and experienced Remote Pharmaceutical Quality Assurance Specialist. This role is vital for ensuring that our products meet the highest standards of quality, safety, and efficacy. As a remote-first organization, you will play a critical role in maintaining compliance with regulatory requirements and internal quality systems from anywhere.
The ideal candidate will possess a thorough understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant pharmaceutical quality standards. You will be responsible for reviewing and approving batch records, deviations, change controls, and other quality-related documentation. Your role will involve participating in internal audits, supporting external regulatory inspections, and contributing to the continuous improvement of quality processes. You will work closely with manufacturing, R&D, and regulatory affairs teams to ensure all activities comply with established procedures and regulatory guidelines. Strong analytical skills, meticulous attention to detail, and excellent written and verbal communication abilities are essential for success in this role.
Key responsibilities include:
This is a fully remote position, offering the flexibility to work from your preferred location. We require candidates with a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field, and a minimum of 3-5 years of experience in pharmaceutical quality assurance or quality control. In-depth knowledge of pharmaceutical regulations and quality systems is essential. Strong analytical, problem-solving, and documentation skills are a must. Join our dedicated team and uphold the highest standards of quality in the pharmaceutical industry.
The ideal candidate will possess a thorough understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant pharmaceutical quality standards. You will be responsible for reviewing and approving batch records, deviations, change controls, and other quality-related documentation. Your role will involve participating in internal audits, supporting external regulatory inspections, and contributing to the continuous improvement of quality processes. You will work closely with manufacturing, R&D, and regulatory affairs teams to ensure all activities comply with established procedures and regulatory guidelines. Strong analytical skills, meticulous attention to detail, and excellent written and verbal communication abilities are essential for success in this role.
Key responsibilities include:
- Reviewing and approving batch manufacturing records (BMRs) and analytical testing results.
- Investigating deviations, out-of-specification (OOS) results, and customer complaints.
- Managing change control processes and ensuring proper implementation.
- Participating in and supporting internal and external audits (e.g., FDA, EMA).
- Developing and updating Standard Operating Procedures (SOPs) and quality guidelines.
- Ensuring compliance with current Good Manufacturing Practices (cGMP) and other regulatory requirements.
- Conducting risk assessments and implementing corrective and preventive actions (CAPAs).
- Collaborating with cross-functional teams to resolve quality issues.
- Monitoring and reporting on key quality metrics and performance indicators.
- Contributing to the overall quality management system (QMS).
This is a fully remote position, offering the flexibility to work from your preferred location. We require candidates with a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field, and a minimum of 3-5 years of experience in pharmaceutical quality assurance or quality control. In-depth knowledge of pharmaceutical regulations and quality systems is essential. Strong analytical, problem-solving, and documentation skills are a must. Join our dedicated team and uphold the highest standards of quality in the pharmaceutical industry.
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6
Pharmaceutical Quality Assurance Specialist (Remote)
Posted 3 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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Lead Remote Pharmaceutical Quality Assurance Specialist
Posted 21 days ago
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Job Description
Our client, a reputable pharmaceutical company committed to improving global health, is seeking a Lead Remote Pharmaceutical Quality Assurance Specialist. This is a critical, fully remote role responsible for ensuring the highest standards of quality and compliance across all pharmaceutical development and manufacturing processes. The successful candidate will lead QA initiatives, conduct audits, and implement robust quality management systems. This position requires a deep understanding of pharmaceutical regulations (GMP, GCP, GLP), excellent analytical skills, and the ability to effectively manage quality processes and teams remotely.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with global regulatory requirements.
- Conduct internal and external audits of manufacturing sites, contract manufacturing organizations (CMOs), and suppliers to ensure compliance.
- Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and change controls, ensuring timely and effective resolution.
- Monitor and analyze quality metrics and trends, reporting key performance indicators (KPIs) to senior management.
- Provide expert guidance on GMP, GCP, and GLP compliance to cross-functional teams.
- Lead and mentor junior QA professionals in a remote working environment.
- Participate in regulatory inspections and provide necessary support and documentation.
- Contribute to risk management activities and the development of mitigation strategies.
- Stay updated on evolving pharmaceutical regulations and industry best practices.
- Manage the lifecycle of quality documentation and records.
- Collaborate effectively with R&D, manufacturing, regulatory affairs, and other departments remotely.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8 years of progressive experience in Pharmaceutical Quality Assurance/Quality Control.
- Extensive knowledge of GMP, GCP, GLP, and other relevant pharmaceutical regulations (e.g., FDA, EMA).
- Proven experience in conducting audits, managing deviations, and implementing CAPAs.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly.
- Demonstrated leadership abilities and experience in managing teams remotely.
- Proficiency in QMS software and digital documentation systems.
- Ability to work independently, manage priorities, and meet strict deadlines.
- Detail-oriented with a commitment to ensuring product quality and patient safety.
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Pharmaceutical Quality Assurance Analyst
Posted today
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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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