Responsibilities
Perform and supervise In-Process Quality Assurance (IPQA) OR QA checks during API manufacturing operations.
Conduct on-line review of Batch Production Records (BPR) and ensure adherence to approved procedures.
Ensure sampling, line clearance, and process compliance as per GMP/cGMP norms.
Identify, record, and support resolution of deviations, non-conformances, and quality incidents during manufacturing.
Support quality investigations and prepare required documentation for audits.
Key Skills
Knowledge of IPQA/QA activities, in-process quality checks, and API/BPR documentation.
Attention to detail, process monitoring, and understanding of GMP documentation.
Valuable communication and teamwork.