To ensure that all pharmaceutical products are manufactured, tested, and released in compliance with regulatory standards, company policies, and Good Manufacturing Practices (GMP), thereby guaranteeing product quality, safety, and efficacy.
Key Responsibilities
Quality Compliance & GMP:
Ensure adherence to Good Manufacturing Practices (GMP), SOPs, and regulatory guidelines (e.g., NAFDAC, WHO, FDA where applicable).
Monitor manufacturing and packaging processes to ensure compliance with approved procedures.
Participate in internal and external audits and regulatory inspections.
Documentation & Record Control:
Review batch manufacturing records (BMR), batch packaging records (BPR), and other quality documents for accuracy and completeness.
Ensure proper documentation practices (GDP) are followed across all departments.
Maintain and control SOPs, specifications, and quality records.
In-Process Quality Assurance:
Perform line clearance before and after production activities.
Conduct in-process checks and ensure compliance with quality standards during manufacturing.
Monitor environmental conditions where required.
Requirements
Bachelor's Degree (B.Sc./HND) in Pharmacy, Microbiology, Biochemistry, Chemistry, or any related science discipline.
Professional certification or membership (e.g. NIPR, or relevant regulatory body) is an added advantage.
Minimum of 5 - 8 years' experience in a pharmaceutical manufacturing company.
Strong knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory requirements (NAFDAC, WHO guidelines).
Experience in documentation review, deviation handling, CAPA, and audit processes.
Proficiency in Microsoft Office applications (Excel, Word, PowerPoint).
Good understanding of quality systems, risk management, and validation processes.