Quality Assurance In-charge

Job Description

Key Responsibilities: Quality System Management: Oversee implementation and maintenance of Quality Management System (QMS). Monitor compliance with cGMP guidelines, SOPs, and regulatory requirements. Documentation & Record Review: Approve and control SOPs, batch records (BMR/BPR), validation protocols, and reports. Review and release of finished product batches after thorough documentation check. Audit Handling: Lead internal and external audits (Regulatory, Customer, Third-party). Prepare audit readiness plans and ensure timely closure of audit observations with CAPA. Deviation, OOS, and CAPA Management: Review and approve deviation reports, OOS investigations, and root cause analysis. Ensure effective implementation and monitoring of CAPAs. Validation & Qualification Oversight: Supervise and approve process validation, cleaning validation, equipment qualification. Review validation master plan and coordinate with concerned departments. Training & Compliance: Develop and execute training programs on GMP, documentation practices, and quality compliance. Maintain training records and ensure staff competence. Change Control & Risk Management: Evaluate and approve change controls, risk assessments, and impact analysis on quality. Promote quality risk management throughout the facility. Team Leadership: Guide and supervise the QA team. Ensure team productivity, skill enhancement, and performance management. Job Type: Full-time Pay: ₹30,000.00 - ₹40,000.00 per month Benefits: Provident Fund Schedule: Day shift Work Location: In person