QA Executive

Cadchem Laboratories Ltd

API Pharmaceutical Plant

QA Executive

Qualification : BSC / MSC or B.Pharma / M.Pharma

Experience : 1-3 years in Pharmaceutical Company

Key Responsibilities

Quality Assurance Operations

• Review and approve Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
• Ensure compliance with cGMP, ICH, WHO, USFDA, EU GMP, and other regulatory requirements.
• Monitor and ensure adherence to SOPs, policies, and quality systems.
• Perform line clearance and in-process checks during API manufacturing.

Documentation & Compliance

• Preparation, review, and control of SOPs, protocols, and formats.
• Review of analytical and manufacturing documents.
• Ensure proper documentation practices as per GDP (Good Documentation Practices).
• Maintain and update Quality Management System (QMS) documents.

Deviations, Change Control & CAPA

• Initiate, investigate, and close deviations, OOS, OOT, and incidents.
• Participate in root cause analysis and implementation of CAPA.
• Handle change control activities related to processes, equipment, and documents.

Validation & Qualification Support

• Assist in process validation, cleaning validation, and equipment qualification.
• Review validation protocols and reports.
• Ensure compliance of validation activities with regulatory guidelines.

Audits & Inspections

• Participate in internal audits, vendor audits, and regulatory inspections.
• Prepare and support regulatory audits (USFDA, WHO, EDQM, etc.).
• Assist in preparation of audit responses and compliance reports.

Training & Continuous Improvement

• Conduct GMP and SOP training for production and QC personnel.
• Support continuous improvement initiatives in QA processes.

Job Types: Full-time, Permanent

Pay: ₹20,000.00 - ₹25,000.00 per month

Work Location: In person