1016 East African Breweries Limited jobs in Nairobi
Senior Pharmaceutical Quality Control Analyst
Posted 19 days ago
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Job Description
Responsibilities:
- Perform complex analytical testing on pharmaceutical raw materials, intermediates, and finished products using various techniques such as HPLC, GC, UV-Vis spectrophotometry, and Karl Fischer titration for projects supporting operations related to **Mombasa, Mombasa, KE** and international markets.
- Develop, validate, and transfer analytical methods according to ICH guidelines and regulatory requirements.
- Analyze and interpret test results, compare them against established specifications, and prepare detailed reports on findings.
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, identify root causes, and recommend corrective and preventive actions (CAPAs).
- Maintain and calibrate laboratory equipment, ensuring its optimal performance and compliance with regulatory standards.
- Ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality systems and regulatory guidelines.
- Review and approve analytical data, method validation reports, and other quality-related documentation.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to support product development and lifecycle management.
- Train and mentor junior quality control analysts, providing guidance on analytical techniques and laboratory procedures.
- Contribute to the continuous improvement of quality control processes and laboratory operations.
- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related life science discipline.
- Minimum of 6 years of hands-on experience in pharmaceutical quality control or analytical development.
- Proficiency in operating and maintaining analytical instrumentation commonly used in pharmaceutical QC (e.g., HPLC, GC, dissolution testers).
- Solid understanding of ICH guidelines, GMP, and other relevant pharmaceutical regulatory requirements.
- Experience with method development and validation is essential.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills, with the ability to clearly document scientific data and findings.
- Proven ability to work independently and manage time effectively in a remote laboratory support role.
- Experience with LIMS (Laboratory Information Management System) is a plus.
Remote Pharmaceutical Quality Control Scientist
Posted 19 days ago
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Job Description
Key Responsibilities:
- Perform a wide range of analytical tests on raw materials, in-process samples, and finished pharmaceutical products using various techniques (e.g., HPLC, GC, UV-Vis, Karl Fischer titration).
- Develop, optimize, and validate analytical methods according to ICH guidelines and pharmacopoeial standards.
- Review and interpret analytical data, ensuring accuracy and compliance with specifications.
- Investigate out-of-specification (OOS) results and deviations, identifying root causes and implementing corrective and preventive actions (CAPAs).
- Maintain accurate and comprehensive laboratory records, including data logs, instrument calibration, and maintenance logs.
- Prepare Certificates of Analysis (CoA) and technical reports for internal stakeholders and regulatory submissions.
- Contribute to the maintenance and improvement of the Quality Management System (QMS).
- Stay updated on the latest scientific advancements, regulatory requirements, and industry best practices in pharmaceutical quality control.
- Participate in internal and external audits as required.
- Collaborate effectively with cross-functional teams in a remote environment to address quality-related issues.
- Ensure laboratory safety protocols are strictly followed.
Qualifications:
- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
- Minimum of 4 years of experience in pharmaceutical quality control or analytical development.
- Hands-on experience with analytical instrumentation such as HPLC, GC, FTIR, UV-Vis spectrophotometry.
- Strong knowledge of GMP, ICH guidelines, and pharmacopoeial standards (USP, EP).
- Proficiency in data analysis and statistical evaluation.
- Excellent documentation and report-writing skills.
- Ability to work independently, manage time effectively, and meet deadlines in a remote setting.
- Strong problem-solving and critical thinking abilities.
- Effective communication and collaboration skills.
- Familiarity with LIMS (Laboratory Information Management System) is an advantage.
Senior Quality Control Manager - Food Manufacturing
Posted 2 days ago
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Job Description
Remote Senior Pharmaceutical Quality Control Analyst
Posted 9 days ago
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Job Description
Responsibilities:
- Perform analytical testing on pharmaceutical materials using various laboratory techniques (e.g., HPLC, GC, spectroscopy, dissolution testing).
- Analyze test data, interpret results, and prepare comprehensive analytical reports.
- Ensure all testing is conducted in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
- Validate analytical methods and instruments as required.
- Troubleshoot analytical instrumentation and resolve laboratory issues.
- Maintain accurate laboratory records and documentation, including logbooks and data files.
- Participate in the investigation of Out-of-Specification (OOS) results and deviations.
- Contribute to the continuous improvement of quality control processes and procedures.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, as needed.
- Stay current with scientific advancements and regulatory expectations in pharmaceutical quality control.
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline. A Master's degree is a plus.
- Minimum of 4 years of experience in pharmaceutical quality control or analytical testing.
- Strong expertise in analytical techniques such as HPLC, GC, UV-Vis spectroscopy, and dissolution testing.
- Thorough understanding of GMP/GLP regulations and quality control principles in the pharmaceutical industry.
- Excellent data analysis, interpretation, and report writing skills.
- Proficiency with laboratory information management systems (LIMS) and relevant software.
- Ability to work independently, manage time effectively, and maintain high levels of accuracy in a remote laboratory setting.
- Strong problem-solving abilities and attention to detail.
- Good written and verbal communication skills.
- Familiarity with method validation and instrument qualification is highly desirable.
- This is a fully remote position, supporting critical quality functions for operations that may involve Mlolongo, Machakos, KE , but offering full remote work flexibility.
Senior Pharmaceutical Quality Control Analyst - Remote
Posted 17 days ago
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Job Description
Responsibilities:
- Develop, validate, and implement analytical test methods for pharmaceutical products.
- Conduct raw material, in-process, and finished product testing.
- Analyze and interpret complex analytical data, generating comprehensive reports.
- Perform stability studies and monitor product shelf-life.
- Investigate deviations and contribute to CAPA development and implementation.
- Ensure compliance with GMP, ICH guidelines, and other relevant regulatory standards.
- Collaborate with R&D, manufacturing, and regulatory teams.
- Maintain detailed and accurate laboratory records and documentation.
- Operate and maintain analytical instrumentation (HPLC, GC, KF, etc.).
- Contribute to process improvements and quality initiatives.
- Bachelor's or Master's degree in Pharmacy, Chemistry, or a related life science field.
- Minimum of 5 years of experience in pharmaceutical quality control or assurance.
- Extensive knowledge of GMP and regulatory requirements.
- Proficiency in analytical techniques and instrumentation.
- Strong data analysis and interpretation skills.
- Excellent written and verbal communication skills.
- Ability to work independently and manage multiple projects remotely.
- Experience with LIMS and electronic data management systems is a plus.
Principal Pharmaceutical Quality Assurance Engineer
Posted 3 days ago
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Job Description
- Lead and manage all aspects of the Quality Assurance (QA) function for pharmaceutical products, ensuring compliance with global regulatory standards (FDA, EMA, etc.).
- Develop, implement, and maintain the company's Quality Management System (QMS), including SOPs, batch records, and validation protocols.
- Oversee the quality control of raw materials, in-process testing, and finished product release.
- Conduct internal audits and host regulatory inspections, ensuring readiness and compliance.
- Investigate deviations, non-conformances, and CAPA (Corrective and Preventive Actions), implementing effective solutions to prevent recurrence.
- Review and approve manufacturing process validation, equipment qualification, and cleaning validation reports.
- Manage change control processes and ensure all changes are properly assessed, documented, and implemented.
- Provide QA oversight for product development, technology transfer, and commercial manufacturing activities.
- Train and mentor QA team members and other personnel on quality systems and regulatory requirements.
- Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and regulatory affairs, to ensure integrated quality approaches.
- Stay current with evolving regulatory expectations and industry best practices in pharmaceutical quality assurance.
- Contribute to strategic quality initiatives and continuous improvement programs.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, Engineering, or a related scientific discipline.
- Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance and Quality Control.
- Extensive knowledge of GMP, GLP, ICH guidelines, and regulatory submission requirements.
- Proven experience in developing, implementing, and managing robust QMS.
- Strong background in validation (process, equipment, cleaning) and batch record review.
- Demonstrated experience in managing deviations, CAPAs, and change controls.
- Excellent leadership, communication, and interpersonal skills, with the ability to influence and drive compliance.
- Experience with sterile manufacturing and aseptic processing is highly advantageous.
- Proficiency in quality risk management principles.
- Ability to work autonomously, manage complex projects, and lead remote teams effectively.
- Familiarity with pharmaceutical manufacturing processes and analytical testing methods.
Remote Quality Control Supervisor - Sanitation Standards
Posted 4 days ago
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Senior Quality Control Manager - Pharmaceutical
Posted 19 days ago
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Job Description
Responsibilities:
- Develop, implement, and manage the company's quality control systems and procedures for pharmaceutical products.
- Oversee all aspects of product testing, including raw materials, in-process samples, and finished goods.
- Ensure compliance with national and international regulatory standards, including GMP, FDA, and ICH guidelines.
- Manage and mentor a remote team of QC analysts and technicians, providing technical guidance and training.
- Review and approve quality control data, batch records, and release documentation.
- Investigate deviations, out-of-specification results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Develop and validate analytical methods to ensure accuracy and reliability of test results.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle.
- Conduct internal audits and support external regulatory inspections.
- Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality control.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in pharmaceutical quality control or quality assurance, with at least 3 years in a management role.
- Extensive knowledge of GMP, quality systems, and regulatory compliance in the pharmaceutical industry.
- Proven experience in analytical method development and validation.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal skills.
- Ability to effectively manage and motivate a remote team.
- Proficiency in quality control laboratory instrumentation and software.
- This is a fully remote position, offering unparalleled flexibility. The nominal administrative base for this role is Mombasa, Mombasa, KE , but the work is performed entirely remotely.
Lead Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
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Job Description
Senior Pharmaceutical Quality Assurance Specialist
Posted 16 days ago
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Job Description
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Conduct internal and external audits of suppliers, contract manufacturers, and internal processes.
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing CAPA (Corrective and Preventive Actions).
- Ensure compliance with cGMP, FDA, EMA, and other relevant regulatory guidelines.
- Participate in regulatory inspections and respond to regulatory inquiries.
- Develop and deliver quality training programs to relevant personnel.
- Monitor key quality metrics and provide regular reports to management.
- Stay updated on evolving regulatory requirements and industry best practices.
- Contribute to the continuous improvement of quality processes and systems.
- Oversee change control processes and risk assessments.
- Manage documentation control processes to ensure accuracy and accessibility.
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 cGMP, ICH guidelines, and other relevant regulatory standards.
- Proven experience in conducting audits and managing QMS.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and decision-making skills.
- Proficiency in documentation review and investigation processes.
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a remote team environment.
- Experience with electronic QMS is a plus.
- Must be legally authorized to work in Kenya.
This is an exceptional opportunity for a seasoned QA professional to contribute significantly to patient safety and product quality in a fully remote capacity, based in **Mombasa, Mombasa, KE**. Join a progressive organization that values expertise, dedication, and the well-being of its remote workforce.