91 Quality Assurance Specialist jobs in Nairobi
Senior Pharmaceutical Quality Assurance Specialist
Posted 1 day ago
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Job Description
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) for pharmaceutical products.
- Conduct internal audits to ensure compliance with GMP, ISO, and other relevant standards.
- Participate in external audits and regulatory inspections.
- Review and approve batch manufacturing records (BMRs) and analytical test results.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints.
- Implement and manage CAPA (Corrective and Preventive Actions) plans.
- Develop and deliver quality-related training to personnel.
- Ensure compliance with all applicable regulatory requirements.
- Manage vendor qualification and auditing processes.
- Oversee change control procedures and documentation.
- Contribute to the validation of equipment, processes, and analytical methods.
- Prepare and submit regulatory documentation as required.
- Monitor industry trends and regulatory updates relevant to pharmaceutical quality.
- Champion a culture of quality and continuous improvement throughout the organization.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP (Good Manufacturing Practices) regulations.
- Experience with ICH guidelines and other international regulatory requirements.
- Proven experience in conducting audits and managing deviations.
- Strong understanding of pharmaceutical manufacturing processes and quality control testing.
- Excellent analytical, problem-solving, and decision-making skills.
- Proficiency in documentation and record-keeping.
- Strong written and verbal communication skills.
- Ability to work independently and manage priorities effectively in a remote setting.
- Experience with quality risk management principles.
- Relevant certifications (e.g., CQE) are a plus.
Senior Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance systems in accordance with cGMP, GCP, and relevant international guidelines.
- Conduct internal and external audits of manufacturing facilities, contract manufacturers, and suppliers.
- Review and approve batch records, validation reports, and other quality-critical documents.
- Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.
- Participate in regulatory inspections and respond to queries from health authorities.
- Develop and deliver quality training programs to personnel involved in pharmaceutical operations.
- Monitor and evaluate product quality and manufacturing processes, identifying areas for improvement.
- Stay updated on evolving regulatory requirements and industry best practices.
- Contribute to the risk management process and ensure its effective implementation.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs.
- Lead quality investigations and root cause analysis for quality events.
- Prepare and present quality metrics and reports to senior management.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of cGMP (Current Good Manufacturing Practices), GCP (Good Clinical Practices), and relevant regulatory guidelines (e.g., FDA, EMA).
- Proven experience in conducting audits and managing quality systems.
- Strong understanding of pharmaceutical manufacturing processes and product lifecycle.
- Excellent analytical, problem-solving, and critical-thinking skills.
- Exceptional written and verbal communication skills, with the ability to document complex findings clearly and concisely.
- Ability to work independently and manage multiple priorities in a remote setting.
- Experience with validation protocols and IQ/OQ/PQ is highly desirable.
- Strong attention to detail and commitment to maintaining the highest quality standards.
Lead Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
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Job Description
Senior Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Conduct internal audits and inspections of manufacturing processes, laboratories, and documentation.
- Manage and coordinate external regulatory inspections (e.g., FDA, EMA) and customer audits.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and change controls.
- Provide quality assurance support for product development, manufacturing, and lifecycle management.
- Ensure compliance with relevant pharmaceutical regulations, guidelines, and standards (GMP, GXP, ICH).
- Train personnel on quality assurance principles and regulatory requirements.
- Contribute to continuous improvement initiatives within the Quality Unit.
- Act as a key liaison between the company and regulatory bodies.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Advanced degree preferred.
- Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, GXP, and other relevant pharmaceutical regulations and guidelines.
- Experience with auditing, deviation management, and CAPA systems.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills, with the ability to present complex information clearly.
- Proven ability to work independently and manage multiple priorities in a remote setting.
- Familiarity with pharmaceutical manufacturing processes and technologies.
- Experience with regulatory submissions and interactions is a plus.
- Detail-oriented and committed to upholding the highest quality standards.
Senior Pharmaceutical Quality Assurance Specialist
Posted 8 days ago
Job Viewed
Job Description
Responsibilities:
- Ensure adherence to Good Manufacturing Practices (GMP) and other relevant quality standards.
- Review and approve batch manufacturing records and quality control data.
- Investigate deviations, out-of-specifications, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Participate in internal and external audits, and support regulatory inspections.
- Develop and maintain Standard Operating Procedures (SOPs) and other quality-related documentation.
- Conduct risk assessments and implement mitigation strategies for quality-related issues.
- Qualify and monitor contract manufacturers and suppliers.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality.
- Contribute to the continuous improvement of the Quality Management System (QMS).
- Provide training and guidance to junior QA staff on quality principles and practices.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8 years of experience in pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of GMP, GLP, and regulatory requirements in the pharmaceutical industry.
- Experience with pharmaceutical product development lifecycle.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent written and verbal communication skills, with the ability to present complex information clearly.
- Proven ability to manage multiple tasks and projects simultaneously in a remote setting.
- Experience with electronic QMS and data management systems is a plus.
- Must be legally authorized to work in Kenya.
Remote Pharmaceutical Quality Assurance Specialist
Posted 9 days ago
Job Viewed
Job Description
Responsibilities:
- Develop and implement pharmaceutical quality assurance strategies and procedures.
- Conduct internal audits and inspections to ensure compliance with GMP and regulatory standards.
- Review and approve batch records, validation protocols, and stability studies.
- Investigate deviations, out-of-specifications (OOS), and customer complaints, implementing CAPAs.
- Manage and maintain quality documentation, including SOPs and training records.
- Collaborate with cross-functional teams on quality-related issues and continuous improvement initiatives.
- Stay abreast of regulatory changes and industry best practices.
- Prepare for and support external regulatory inspections.
- 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 relevant regulatory requirements.
- Proven experience with quality management systems, audits, and deviation investigations.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent written and verbal communication skills for remote collaboration.
- Proficiency in using quality management software and standard office applications.
- Ability to work autonomously and manage time effectively in a remote setting.
Remote Pharmaceutical Quality Assurance Specialist
Posted 9 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop and maintain the company's Quality Management System (QMS) in accordance with regulatory standards.
- Conduct internal audits and support external regulatory inspections.
- Review and approve batch production records and associated documentation.
- Investigate deviations, non-conformances, and Out-of-Specification (OOS) results, implementing corrective and preventive actions (CAPA).
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant pharmaceutical regulations.
- Participate in process validation activities and change control procedures.
- Contribute to the development and review of Standard Operating Procedures (SOPs).
- Train personnel on quality assurance procedures and GMP principles.
- Monitor and analyze quality metrics to identify trends and areas for improvement.
- Liaise with regulatory bodies and support drug submission processes.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Master's degree or equivalent experience in Pharmaceutical Sciences is preferred.
- Minimum of 5 years of experience in pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements (e.g., FDA, EMA).
- Experience with QMS, CAPA systems, change control, and deviation management.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills for remote collaboration.
- Ability to work independently and manage time effectively in a remote setting.
- Proficiency in using quality management software and standard office applications.
- Experience in pharmaceutical development and manufacturing processes.
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Remote Pharmaceutical Quality Assurance Specialist
Posted 10 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with cGMP, ICH, and other relevant regulatory guidelines.
- Conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers to ensure compliance.
- Review and approve quality-related documents, including Standard Operating Procedures (SOPs), batch records, validation protocols, and reports.
- Investigate deviations, Out-of-Specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Monitor and analyze quality metrics, identifying trends and areas for continuous improvement.
- Provide training and guidance to personnel on quality assurance principles and regulatory requirements.
- Participate in regulatory inspections and respond to inquiries from health authorities.
- Evaluate and approve changes to manufacturing processes, equipment, and materials.
- Ensure that all pharmaceutical products meet defined quality standards and specifications.
- Stay up-to-date with evolving global regulatory requirements and industry best practices.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality is integrated throughout the product lifecycle.
- Manage the document control system, ensuring all quality-related documents are current, accurate, and accessible.
- Contribute to risk management activities and quality by design (QbD) initiatives.
- Perform batch record reviews and release, ensuring compliance before product distribution.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant international regulatory guidelines (e.g., FDA, EMA, WHO).
- Proven experience in conducting audits, investigations, and managing CAPA systems.
- Strong understanding of pharmaceutical manufacturing processes, quality control testing, and product release procedures.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills, with the ability to prepare clear and concise reports and documentation.
- Proficiency in using QMS software and other relevant quality management tools.
- Ability to work independently, manage time effectively, and meet deadlines in a remote setting.
- Experience with regulatory submissions and interactions with health authorities is a plus.
- This is a significant opportunity for a seasoned QA professional to impact pharmaceutical quality on a global scale, all while enjoying the benefits of a remote work arrangement.
Remote Pharmaceutical Quality Assurance Specialist
Posted 10 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS).
- Review and approve manufacturing batch records and associated documentation.
- Investigate deviations, out-of-specification results, and customer complaints.
- Manage change control processes and ensure all changes are properly documented and implemented.
- Conduct internal audits and support external regulatory inspections and audits.
- Develop and implement Corrective and Preventive Actions (CAPA).
- Ensure compliance with cGMP, GLP, and other relevant regulatory requirements.
- Collaborate with R&D, manufacturing, and regulatory affairs departments on quality matters.
- Train personnel on quality policies and procedures.
- Maintain and update quality-related documentation, SOPs, and work instructions.
- Monitor quality metrics and contribute to continuous improvement initiatives.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 5 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements for pharmaceuticals.
- Proven experience in auditing, deviation investigation, and CAPA management.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and accuracy.
- Proficient in using QMS software and standard office applications.
- Strong written and verbal communication skills for effective remote collaboration.
- Ability to work independently and manage workload effectively in a remote setting.
Remote Sanitation Quality Assurance Specialist
Posted 15 days ago
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