Officer Quality Assurance
Core
Ensuring compliance with Good Manufacturing Practices (GMP) and data integrity in an oral dosage facility, including manufacturing/packing process checks and batch record management.
Role type
Quality Assurance Officer (Manufacturing)
Builds
Compliant pharmaceutical batches and documentation
Domain
Pharmaceuticals / Oral Dosage Manufacturing
Required skills
GMP compliance, data integrity, batch record review, line clearance, in-process checks, sample management, SOP adherence, instrument calibration, investigation support
Preferred skills
ISO training, safety practices (COBC)
Responsibilities
Monitor compliance of current Good Manufacturing Practices in the Oral dosage facility & follow GDP with data-integrity compliance; Perform line clearance and in-process checks at different stages of batch manufacturing and packing; Collect and manage control, stability, and validation samples; Issue and review batch records and executed batch documents; Calibrate IPQA instruments and maintain related records; Assist in investigation activities; Follow all practices related to safety and COBC.