Executive-Quality Assurance
Shalina Healthcare
Remote
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.
- 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.