6,554 Senior Pharmaceutical Quality Control Specialist jobs in Kenya
Lead Pharmaceutical QA/QC Specialist (Remote)
Posted 21 days ago
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Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance (QA) and Quality Control (QC) systems.
- Oversee the execution of analytical testing for raw materials, in-process samples, and finished products.
- Ensure compliance with cGMP, ICH guidelines, and other relevant regulatory standards.
- Write, review, and approve Standard Operating Procedures (SOPs), batch records, and validation protocols.
- Manage deviations, Out-of-Specification (OOS) results, and CAPA investigations.
- Conduct internal audits and support external regulatory inspections.
- Train and mentor QA/QC personnel.
- Analyze quality data to identify trends and implement continuous improvement initiatives.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality and compliance.
- Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality management.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. M.Sc. or Ph.D. is a plus.
- Minimum of 7 years of progressive experience in pharmaceutical Quality Assurance and/or Quality Control.
- In-depth knowledge of cGMP regulations, ICH guidelines, and pharmaceutical manufacturing processes.
- Proven experience in managing analytical testing, method validation, and stability studies.
- Strong understanding of quality management systems, including deviation management, CAPA, and change control.
- Excellent documentation, analytical, and problem-solving skills.
- Strong leadership and team management capabilities.
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a remote setting.
- Experience with electronic quality management systems (eQMS) is beneficial.
- Detail-oriented with a strong commitment to quality and compliance.
This is a significant opportunity to lead quality initiatives and ensure the highest standards in pharmaceutical manufacturing, all within a remote work structure. You will play a crucial role in safeguarding product integrity and patient safety, contributing to operations relevant to **Nyeri, Nyeri, KE**, and the broader pharmaceutical landscape, as a valued member of our remote-first organization.
Pharmaceutical Quality Control Specialist
Posted 13 days ago
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Remote Pharmaceutical Quality Control Specialist
Posted 22 days ago
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Senior Pharmaceutical Quality Control Specialist
Posted 15 days ago
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Pharmaceutical Quality Control Analyst
Posted 22 days ago
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Job Description
Key Responsibilities:
- Perform routine and non-routine analytical testing of pharmaceutical materials using techniques such as HPLC, GC, UV-Vis, FTIR, and Karl Fischer titration.
- Prepare reagents, solutions, and standards required for testing.
- Document all testing procedures and results accurately and promptly in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Analyze and interpret test data, comparing results against established specifications.
- Investigate out-of-specification (OOS) results and deviations, participating in root cause analysis.
- Calibrate and maintain laboratory equipment, ensuring proper functioning and performance.
- Participate in method validation and verification activities.
- Maintain a clean and organized laboratory environment.
- Assist in the preparation of Certificates of Analysis (CoA).
- Stay updated with relevant pharmacopoeial standards (e.g., USP, EP) and regulatory requirements.
Qualifications:
- Bachelor's degree in Chemistry, Pharmacy, Biotechnology, or a related scientific field.
- 1-3 years of experience in a pharmaceutical quality control laboratory setting.
- Hands-on experience with common analytical instruments (HPLC, GC, UV-Vis).
- Knowledge of GMP, GLP, and relevant regulatory guidelines.
- Strong analytical and problem-solving skills.
- Meticulous attention to detail and accuracy in data recording.
- Good written and verbal communication skills.
- Ability to work effectively both independently and as part of a team.
- Proficiency in using laboratory information management systems (LIMS) is a plus.
This position offers a hybrid work arrangement, combining essential on-site laboratory work with remote flexibility for data analysis and reporting.
Remote Senior Pharmaceutical Quality Control Specialist
Posted 22 days ago
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Job Description
Responsibilities:
- Perform analytical testing on raw materials, intermediates, and finished pharmaceutical products.
- Develop, validate, and transfer analytical methods.
- Operate and maintain analytical instrumentation (HPLC, GC, Spectrophotometers, etc.).
- Document all testing activities accurately and in compliance with GMP/GLP.
- Investigate out-of-specification (OOS) results and implement CAPA.
- Review and approve batch records and analytical data.
- Ensure compliance with pharmacopeial standards and regulatory requirements.
- Collaborate with cross-functional teams to resolve quality issues.
- Contribute to the continuous improvement of QC processes and systems.
- Maintain laboratory equipment calibration and qualification logs.
- Bachelor's or Master's degree in Chemistry, Pharmacy, or a related life science field.
- Minimum of 6 years of experience in pharmaceutical quality control.
- Extensive hands-on experience with analytical techniques (HPLC, GC, UV-Vis, etc.).
- Strong knowledge of GMP, GLP, and regulatory guidelines.
- Experience with method validation and OOS investigations.
- Excellent attention to detail and accuracy in documentation.
- Strong problem-solving and analytical skills.
- Effective remote communication and interpersonal skills.
- Ability to work independently and manage priorities in a remote setting.
- Must be based in Kenya and available to work within Kenyan business hours.
Lead Pharmaceutical Quality Control Scientist
Posted 7 days ago
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Principal Pharmaceutical Quality Control Scientist
Posted 21 days ago
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Key Responsibilities:
- Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, UV-Vis, FTIR, and dissolution testing.
- Oversee and conduct stability studies according to ICH guidelines to assess product shelf-life and storage conditions.
- Review and approve batch records, analytical data, and quality control reports to ensure product quality and regulatory compliance.
- Investigate deviations, out-of-specification (OOS) results, and out-of-trend (OOT) data, determining root causes and implementing corrective and preventive actions (CAPAs).
- Contribute to the design and execution of validation protocols for analytical methods and equipment.
- Ensure that all quality control activities comply with cGMP, FDA, and other relevant regulatory agency requirements.
- Train and mentor junior QC scientists and technicians, providing technical guidance and support.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to resolve quality issues and support product lifecycle management.
- Maintain laboratory equipment, ensuring proper calibration, maintenance, and documentation.
- Stay abreast of new scientific advancements, regulatory changes, and industry best practices in pharmaceutical quality control.
Qualifications:
- Master's or Ph.D. in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or a related field.
- A minimum of 10 years of experience in pharmaceutical quality control, with at least 3 years in a lead or principal scientist role.
- Extensive hands-on experience with a variety of analytical techniques relevant to pharmaceutical quality control.
- Strong knowledge of cGMP regulations, ICH guidelines, and pharmacopeial standards (USP, EP).
- Proven experience in method validation, OOS investigations, and CAPA management.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong leadership, communication, and interpersonal skills, with the ability to effectively manage remote teams and projects.
- Proficiency in laboratory information management systems (LIMS) and other relevant software.
- Detail-oriented with a commitment to accuracy and quality.
Lead Pharmaceutical Quality Control Analyst
Posted 22 days ago
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Remote Pharmaceutical Quality Control Analyst
Posted 22 days ago
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