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Hetero Labs Limited logo
Quality Assurance Chemist Hetero Labs Limited

0.0 - 4.0 years

0 Lacs

Visakhapatnam, Andhra Pradesh, India

On-site

Key Responsibilities: Documentation and Compliance: Review batch manufacturing records (BMR) and batch packing records (BPR) for completeness and compliance with Good Manufacturing Practices (GMP). Prepare, review, and approve standard operating procedures (SOPs), work instructions, and specifications. Ensure compliance with pharmacopeial standards (USP, BP, IP, EP) and regulatory requirements (FDA, WHO, ICH, etc.). Batch Release: Evaluate and approve batch documentation for the release of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs). Ensure that all deviations, change controls, and out-of-specification (OOS) results are resolved prior to batch release. Audits a...

Posted 2 months ago

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