Associate Manager – External Quality

About the role

Shalina Healthcare is seeking an Associate Manager – External Quality to lead quality oversight of contract manufacturers across Nigeria. The role will act as the regional representative for contract manufacturing organisations (CMOs), ensuring compliance with Good Manufacturing Practices (GMP) and supporting new product launches.

Key responsibilities

• Monitor and audit contract manufacturers in the Nigeria region.
• Provide quality oversight at contract manufacturing sites and act as the regional CMO representative.
• Inspect finished goods, review batch records, and approve batch releases.
• Support new third‑party product launches by reviewing finished‑product data.
• Oversee shop‑floor activities for oral solid dosage, oral liquids, external and sterile formulations.
• Execute process validation and stability studies, reviewing all related data.
• Prepare APQR reports, witness manufacturing, and analyse finished products.
• Conduct quality audits of contract manufacturers and manage CMO coordination.

Required profile

• Minimum 7 years experience in external quality within a GMP environment.
• Strong exposure to regulatory inspections and GMP/GLP practices on the shop floor.
• Independent decision‑maker with ability to work cross‑functionally and communicate with external stakeholders.
• Pharmacy degree (B.Pharm or M.Pharm) or a science degree with relevant experience.

Required skills

• Good Manufacturing Practice (GMP)
• Good Laboratory Practice (GLP)
• Process validation
• Stability studies
• APQR preparation
• Batch record review
• Quality audits