- The Associate Manager - Quality Assurance (External Manufacturing) is responsible for overseeing and ensuring compliance of all externally manufactured pharmaceutical products with regulatory requirements, company quality standards, and GMP guidelines.
- This role involves managing contract manufacturing organizations (CMOs), conducting audits, reviewing documentation, and ensuring product quality throughout the supply chain.
Key Responsibilities
External Manufacturing Oversight:
- Ensure all contract manufacturers comply with GMP, regulatory, and company quality standards.
- Act as the primary QA contact for all external manufacturing partners.
Vendor Qualification & Audits:
- Perform qualification, requalification, and periodic audits of CMOs, suppliers, and service providers.
- Prepare audit reports and follow up on corrective and preventive actions (CAPAs).
Batch Documentation & Release:
- Review and approve batch manufacturing records, analytical reports, and related documents from CMOs.
- Support or authorize batch release in compliance with regulatory requirements.
Quality Systems Management:
- Ensure implementation of quality systems at external sites (deviations, change controls, CAPA, OOS/OOT).
- Monitor and track quality metrics for external manufacturing operations.
- Ensure products meet NAFDAC, WHO, and other applicable regulatory requirements.
- Support regulatory submissions and inspections related to external manufacturing.
Deviation & Investigation Handling:
- Review and approve deviations, investigations, and CAPAs from external partners.
- Ensure timely closure and effectiveness of corrective actions.
Change Control Management:
- Evaluate and approve changes related to materials, processes, and equipment at CMOs.
- Assess impact on product quality and regulatory compliance.
- Experience: 8 - 10 years of experience in Quality Assurance within the pharmaceutical industry
- Experience with external manufacturing or contract manufacturing organizations (CMOs) is highly preferred
- Strong knowledge of GMP, GDP, and regulatory requirements (NAFDAC, WHO,)
- Experience in auditing and vendor management
- Excellent documentation review and attention to detail
- Strong analytical and problem-solving skills
- Effective communication and stakeholder management
- Ability to work independently and manage multiple priorities