Job Description
Job Summary
- The Quality Assurance Manager holds the critical role of ensuring that all pharmaceutical products meet stringent regulatory and internal quality standards.
- This role demands vigilance, scientific rigor, and leadership to maintain compliance with cGMP, WHO, NAFDAC, and international regulatory bodies.
- The QA Manager is the company’s final defense against compromise, safeguarding product integrity, patient safety, and company reputation.
Key Responsibilities
Quality Management System (QMS):
- Develop, implement, and maintain QMS in alignment with regulatory standards (NAFDAC, WHO-GMP, ISO 9001).
- Ensure continuous improvement of QMS through regular audits and management reviews.
Compliance & Documentation:
- Oversee compliance with cGMP, GLP, and SOPs across production, QC, and packaging lines.
- Ensure accurate and timely documentation, batch record reviews, deviations, and change controls.
Audits & Inspections:
- Lead internal audits, host external audits (regulatory bodies, clients), and manage CAPAs.
- Prepare the site for regulatory inspections and ensure timely closure of observations.
Process & Product Oversight:
- Monitor validation of processes, cleaning, and equipment.
- Oversee product release based on conformance to specifications.
Training & Leadership:
- Train and mentor QA personnel and cross-functional teams on quality systems and cGMP updates.
- Foster a culture of quality and ownership across all departments.
Vendor & Supplier Quality:
- Evaluate and audit raw material suppliers and third-party contractors.
- Ensure traceability and quality of materials throughout the supply chain.
Educational Qualifications
- Bachelor’s Degree in Pharmacy (B.Pharm), Pharmaceutical Sciences, Microbiology, Biochemistry, or related field.
- Advanced degrees (M.Sc., MBA) in Quality Management or Regulatory Affairs are an advantage.
- Certification in ISO 9001:2015, Six Sigma, or cGMP is highly desirable.
Experience:
- Minimum 5 - 7 years of relevant experience in QA/QC in a pharmaceutical manufacturing environment.
- At least 2 years in a supervisory or managerial role.
- Proven experience managing regulatory inspections and internal audits.
- Familiarity with sterile and non-sterile production environments is a plus.
Other Requirements:
- Must be registered with relevant professional bodies (e.g., PCN, NAFDAC-recognised body).
- Must be conversant with national and international pharmaceutical laws and regulations.
- Must exhibit ethical integrity and professional discretion.
- Flexibility to work extended hours when required.
- Strong leadership presence and ability to make high-stakes decisions under pressure.
Required Skills and Competencies:
- Deep knowledge of current Good Manufacturing Practices (cGMP), quality control principles, and pharmaceutical regulations.
- Strong analytical and problem-solving skills.
- High attention to detail and documentation accuracy.
- Excellent communication and interpersonal skills.
- Proficiency in Quality Management Software and ERP systems (e.g., Odoo, SAP, TrackWise).
- Ability to lead under pressure and drive cross-functional coordination.
- Root Cause Analysis (RCA) and risk management expertise.