Job Description
Key Responsibilities
Testing and Analysis:
- Conduct routine and non-routine testing of raw materials, in-process samples, and finished pharmaceutical products.
- Perform analytical tests, including but not limited to HPLC, UV-Vis spectroscopy, titration, and microbial analysis.
- Ensure compliance with established quality standards, specifications, and Good Laboratory Practices (GLP).
Documentation and Reporting:
- Accurately document all testing procedures, results, and deviations.
- Prepare and submit comprehensive reports on testing outcomes to the Quality Control Manager.
- Maintain records in compliance with regulatory requirements (e.g., FDA, WHO, NAFDAC).
Compliance and Regulatory Standards:
- Ensure adherence to pharmaceutical quality standards such as GMP, GLP, and ICH guidelines.
- Participate in internal and external audits, including regulatory inspections, as required.
- Implement corrective and preventive actions (CAPAs) for identified quality issues.
Equipment and Instrumentation:
- Calibrate, maintain, and troubleshoot laboratory equipment to ensure optimal performance.
- Verify the functionality of laboratory instruments and address malfunctions promptly.
- Maintain an inventory of laboratory supplies and ensure the availability of necessary reagents.
Collaboration and Coordination:
- Work closely with production, QA, and R&D teams to resolve quality-related issues.
- Support investigations into non-conforming products or deviations from standard procedures.
- Assist in the development and validation of new testing methods and procedures.
Training and Development:
- Participate in training programs to stay updated on new quality control techniques and regulatory changes.
- Provide guidance to junior laboratory staff or interns as needed.
Qualifications
Education:
- Bachelor's Degree in Chemistry, Biochemistry, Microbiology, Pharmacy, or a related field.
Experience:
- Minimum of 2–3 years of experience in quality control within a pharmaceutical manufacturing environment.
- Proficiency in laboratory techniques and use of analytical instruments.
Skills and Competencies:
- Strong attention to detail and analytical skills.
- Good understanding of pharmaceutical regulatory requirements (e.g., GMP, GLP, and ICH guidelines).
- Excellent documentation and record-keeping abilities.
- Proficiency in Microsoft Office Suite and laboratory data management systems.
- Strong communication and teamwork skills.
Work Environment:
- Laboratory setting with potential exposure to chemicals and biohazards.
- May require working flexible hours, including weekends, to meet production timelines