Quality Management System (QMS)
- Manage and maintain the site Quality Management System (QMS) in compliance with cGMP requirements.
- Review, approve, and maintain departmental SOPs, policies, protocols, and technical documents.
- Review and approve Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
- Govern Change Controls, Risk Assessments, Deviations, Investigations, OOS/OOT, CAPA, customer complaints, and product recalls.
- Ensure proper documentation control and compliance with quality procedures.
Quality Assurance & Compliance
- Ensure compliance with cGMP, GLP, GDP, and regulatory standards.
- Conduct line clearances for dispensing, manufacturing, filling, and packing operations.
- Manage product release processes for raw materials, intermediates, and finished goods.
- Review and approve packaging artwork and quality documentation.
Qualification & Validation
- Lead equipment, utility, facility, and process qualification activities.
- Manage DQ, IQ, OQ, PQ protocols and execution.
- Drive process validation and cleaning validation programs.
- Ensure all validation activities are completed as per regulatory requirements.
Audit & Inspection Management
- Conduct self-inspections and internal audits.
- Lead customer, regulatory, and third-party audits.
- Ensure timely CAPA implementation and closure.
- Maintain audit readiness at all times.
Laboratory & Instrument Management
- Oversee laboratory operations and testing activities.
- Ensure calibration of laboratory and production equipment through NABL-accredited laboratories.
- Supervise troubleshooting and maintenance of quality control instruments.
- Maintain laboratory documentation and records.
Environmental & Regulatory Monitoring
- Coordinate testing of:
- Ambient Air Quality
- Drinking Water
- Effluent Water
- Noise Levels
- Lux Levels
- Ensure compliance with FMCG and food safety standards.
Team Management & Training
- Lead and supervise QA/QC teams.
- Conduct quality-related training programs.
- Develop team competencies and quality awareness.
- Ensure adherence to training schedules and compliance programs.
Cross-Functional Coordination
- Work closely with Production, Stores, Procurement, and other departments.
- Support production operations when required.
- Drive continuous improvement initiatives and quality culture across the facility.
Performance Monitoring & Reporting
- Define and monitor Quality KPIs.
- Analyze trends and implement corrective actions.
- Drive cost optimization initiatives without compromising product quality.
- Prepare quality reports and management reviews.