About the Role
Shalina Healthcare is a market leader dedicated to making quality healthcare products affordable and accessible across Africa. With over thirty years of operational excellence, we partner with top-tier facilities to deliver life-saving medicines to millions. We are currently looking for a dedicated Associate Manager – Quality Assurance (External Manufacturing) to join our dynamic team and uphold our rigorous quality standards across our supply chain.
Key Responsibilities- Ensure all contract manufacturing organizations comply strictly with GMP, regulatory, and internal company quality standards.
- Perform qualification, requalification, and periodic audits of CMOs, suppliers, and service providers, managing CAPA follow-ups.
- Review and approve batch manufacturing records, analytical reports, and related documentation to support timely product release.
- Manage external quality systems including deviations, change controls, out-of-specification results, and trend monitoring.
- Maintain full compliance with NAFDAC, WHO, and other regional regulatory requirements for all externally sourced products.
- Evaluate and approve operational changes related to materials, processes, and equipment at external partner facilities.
- Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific discipline.
- 8 to 10 years of progressive quality assurance experience within the pharmaceutical manufacturing industry.
- Demonstrated expertise working with contract manufacturing organizations and external partners is highly preferred.
- Comprehensive knowledge of GMP, GDP, and regulatory frameworks including NAFDAC and WHO guidelines.
- Strong capabilities in conducting quality audits, risk assessment, root-cause analysis, and technical document review.
- Exceptional interpersonal, communication, and stakeholder management skills to collaborate effectively across borders.
- Competitive salary and performance-based incentive structures.
- Comprehensive medical and health insurance coverage.
- Opportunities for professional growth and international career development within a market-leading organization.