Key Responsibilities

- Handle and coordinate Change Control activities, including impact assessment, implementation, and closure.

- Prepare, review, and control SOPs, specifications, formats, and other GMP documents.

- Manage SOP revisions and ensure timely review, approval, implementation, and training.

- Support and review Equipment Qualification activities such as DQ, IQ, OQ, and PQ.

- Handle Deviation investigations, assessment, documentation, and closure.

- Coordinate and review Process Validation protocols and reports, including validation planning, execution, data review, deviation assessment, and final report approval.

- Handle Cleaning Validation activities, including preparation/review of protocols and reports, sampling plans, acceptance criteria, swab/rinse sampling, recovery studies, and evaluation of analytical results.

- Coordinate CAPA identification, implementation, effectiveness checks, and closure.

- Perform/support Root Cause Analysis (RCA)



using appropriate investigation tools such as 5-Why and Fishbone Analysis.

- Review BPR/BMR (Batch Production/Manufacturing Records) for completeness, compliance, and adherence to approved procedures.

- Ensure proper review of manufacturing and packing documentation before batch release/approval as applicable.

- Monitor compliance with GMP, SOPs, data integrity, and quality systems.

- Coordinate with Production, QC, Engineering, Warehouse, and other departments for investigation and quality-related activities.

- Support investigation of process/product-related quality issues and implementation of corrective and preventive actions.

- Maintain QA documentation and ensure timely closure of assigned quality-system activities.

- Provide QA support for API manufacturing processes and demonstrate positive understanding of manufacturing operations and process controls.

📌 Quality Assurance Executive (Dera Bassi)
🏢 Cadchem
📍 Dera Bassi