Quality Assurance Executive

Cadchem; Dera Bassi; On-site; INR 600,000 - 900,000; Full time

Job summary

Cadchem is seeking a QA specialist to oversee GMP-compliant quality systems in manufacturing. The role involves coordinating Change Control, deviations, and validation activities across Production, QC, and Engineering to ensure strict compliance and traceability.

You will review and approve SOPs, BPR/BMR, and packing documentation, perform RCA using 5-Why and Fishbone methods, and drive CAPA closures through systematic investigations and training.

Responsibilities

• Coordinate Change Control activities: impact assessment, implementation, and closure.
• Prepare and control SOPs, specifications, formats, and GMP documents.
• Manage SOP revisions with timely review, approval, implementation and training.
• Support Equipment Qualification activities: DQ/IQ/OQ/PQ.
• Investigate and close deviation events with documentation.
• Review Process Validation protocols: planning, execution, data review, final report.
• Coordinate Cleaning Validation protocols, sampling plans, and reports.
• Coordinate CAPA identification, implementation, and closure.
• Perform Root Cause Analysis using 5-Why and Fishbone methods.
• Review BPR/BMR for completeness and compliance.
• Review manufacturing/packing docs before batch release.
• Ensure GMP, SOPs, data integrity and quality systems compliance.
• Coordinate with Production, QC, Engineering, Warehouse for QA activities.
• Support investigations of process/quality issues and CAPA.
• Maintain QA documentation and timely closure of quality-system tasks.
• Provide QA support for API manufacturing processes and process controls.

Job description

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 good understanding of manufacturing operations and process controls.