QA-IPQA – Job Responsibilities

Experience Require = 05 to 06 year

Note: Priority API Experience only

- Perform in-process quality assurance (IPQA) activities during API manufacturing operations.
- Monitor manufacturing processes and ensure compliance with BMR/BPR, SOPs, GMP, and safety requirements.
- Verify line clearance, equipment status, cleaning status, and material identification before processing.
- Monitor critical process parameters and in-process controls at defined stages.
- Review and verify manufacturing and packaging records for completeness and compliance.
- Report and support investigation of deviations, OOS/OOT, incidents, and non-conformances.
- Ensure proper documentation and ALCOA+ data integrity practices.
- Coordinate with Production, QC, Warehouse, Engineering, and QA for quality-related activities.
- Support validation, qualification, change control, CAPA, and audit activities.
- Ensure compliance with applicable GMP and regulatory requirements throughout manufacturing.

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Skillset Required: API manufacturing, In-process quality assurance (IPQA), Manufacturing process monitoring, BMR, BPR, SOPs, GMP, Safety requirements, Line clearance verification, Equipment status verification, Cleaning status verification, Material identification, Critical process parameters monitoring, In-process controls, Manufacturing record review, Packaging record review, Deviation investigation, OOS (Out of Specification) investigation, OOT (Out of Trend) investigation, Incident reporting, Non-conformance reporting, Documentation, ALCOA+ data integrity, Cross-departmental coordination, Production, Quality Control (QC), Warehouse management, Engineering collaboration, Quality Assurance coordination, Validation, Qualification, Change control, CAPA, Audit activities, Regulatory compliance

📌 QA-IPQA (India)
🏢 Easebiz Fintech Solutions
📍 India