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