Executive, IPQA
Core
Responsible for line clearance, process validation, in-process testing, and cGMP compliance monitoring in sterile manufacturing operations.
Role type
Quality Assurance Specialist (Sterile Manufacturing)
Builds
Sterile pharmaceutical products
Domain
Pharmaceutical manufacturing / Sterile processing
Required skills
In-Process Quality Controls (IPQC), Aseptic Process Simulation (Media Fill) Monitoring, Line Clearance, Batch Record Review, Good Documentation Practices (GDP), Regulatory & Compliance Knowledge
Preferred skills
Environmental Monitoring, Qualification Activities
Technologies
CIP, SIP, Autoclave, Filter Integrity
Responsibilities
Perform line clearance before dispensing, manufacturing, filling, inspection, sealing, labelling, and packing; Conduct process validation, cleaning validation, hold time studies, media fill, and routine batch sampling; Review executed BMRs and BPRs; Perform in-process tests at different stages; Monitor cGMP compliance at the shop floor; Review calibration certificates and printouts (CIP, SIP, autoclave, filter integrity); Maintain issuance/reconciliation records for environment monitoring materials; Participate in media fill simulation studies and manufacturing area qualification activities.