Assistant Manager, Quality Assurance
Core
Ensuring product quality, compliance, and integrity across pharmaceutical manufacturing operations through batch release, in-process QA, and regulatory adherence.
Role type
Assistant Manager, Operational Quality Assurance
Builds
Pharmaceutical products compliant with cGMP and regulatory standards
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
cGMP knowledge, Quality Management Systems (QMS), batch record review, batch release, deviation management, CAPA, change control, equipment qualification, validation, root cause analysis, audit support
Preferred skills
None explicitly stated as preferred (all listed under required)
Technologies
SAP
Responsibilities
Review and approve Work Order Packages and batch documentation; Verify Certificates of Analysis; Perform batch disposition and release in SAP; Prepare and approve quality documents (SOPs, VMPs); Oversee equipment qualification and calibration; Conduct In-Process Quality Assurance (IPQA) on the floor; Lead investigations for deviations, incidents, and OOS/OOT events
Seniority
Mid-Senior, hands-on IC