Officer, Manufacturing Process Operations
Core
Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches.
Role type
Manufacturing Process Operations Officer
Builds
Drug product batches (stability and commercial)
Domain
Pharmaceutical manufacturing
Required skills
cGMP compliance, SOP execution, batch record review, equipment qualification (IQ/OQ/PQ), material movement management, training delivery, area and equipment sanitation
Preferred skills
M. Pharm degree
Technologies
Batch Manufacturing Records, Batch Packing Records, Process Study Protocols, Process Study Reports
Responsibilities
Supervise manufacturing, processing, packaging and holding of drug product; Maintain area and equipment in orderly, sanitized condition per cGMP; Perform online documentation; Impart training on operation and cleaning SOPs; Coordinate and perform IQ/OQ/PQ for new equipment/systems; Handle and manage material movement; Review and execute Batch Manufacturing/Packaging Records and Process Study documents.