We are looking for an IPQA Executive to monitor and ensure in-process quality during manufacturing and packing operations in our API facility. The ideal candidate will be responsible for real-time quality assurance, GMP compliance, and documentation control throughout the production lifecycle.
Key Responsibilities:
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Perform in-process checks during various stages of API manufacturing
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Ensure compliance with cGMP and approved procedures on the shop floor
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Review and verify batch manufacturing records (BMR) and equipment usage logs
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Monitor critical process parameters and sampling activities
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Report and investigate deviations, non-conformances, and OOS/OOT results
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Provide line clearance for manufacturing and cleaning operations
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Coordinate with production and QA teams for quality-related decisions
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Participate in internal audits and continuous improvement initiatives
Key Skills & Knowledge:
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Strong understanding of cGMP and API manufacturing processes
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Valuable documentation and observation skills
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Familiarity with QMS tools like deviation, CAPA, and change control
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Ability to work in shifts and on the shop floor
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Knowledge of regulatory guidelines (ICH, WHO, USFDA)