QA - Sr.Executive HLL-IX

• Ensure compliance with cGMP, GLP, SOPs, and regulatory requirements .
• Perform shop-floor QA activities , including line clearance and batch documentation review.
• Review BMR/BPR, SOPs, protocols, specifications, and validation documents .
• Initiate and investigate deviations, OOS/OOT, incidents, complaints, and CAPA .
• Manage change controls and ensure timely implementation and closure.
• Coordinate with Production, QC, Engineering, and other departments for quality-related activities.
• Support internal, customer, and regulatory audits and ensure effective CAPA implementation.
• Ensure data integrity and good documentation practices (GDP) .
• Monitor compliance with manufacturing, cleaning, environmental, and validation requirements.
• Prepare and review QA reports and maintain quality-system records.

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