Head Quality Control & Quality Assurance

Department Name: QA/QC

Designation: HeadResponsibility:

1. Quality Management System (QMS)

• Establish, implement, and maintain the Quality Management System in compliance with cGMP, GLP, and regulatory requirements.
• Ensure all departments follow quality policies, procedures, and regulatory guidelines.
• Oversee quality compliance across manufacturing, laboratory, and warehouse operations.

2. Quality Assurance (QA) Oversight

• Approve Standard Operating Procedures (SOPs), protocols, and reports.
• Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
• Manage change control, deviations, OOS (Out of Specification), OOT, and CAPA systems.
• Ensure data integrity and documentation compliance.

3. Quality Control (QC) Management

• Supervise analytical and microbiological testing of raw materials, in-process samples, finished products, and stability samples.
• Ensure testing is performed according to validated methods and pharmacopeial standards such as United States Pharmacopeia (USP), British Pharmacopoeia (BP), and Indian Pharmacopoeia (IP).
• Ensure calibration and qualification of laboratory instruments.

4. Regulatory Compliance

• Ensure compliance with national and international regulatory requirements such as U.S. Food and Drug Administration (FDA), World Health Organization (WHO), and Central Drugs Standard Control Organization (CDSCO).
• Coordinate regulatory inspections and audits.
• Ensure readiness for regulatory audits and customer audits.

5. Validation and Qualification

• Oversee process validation, cleaning validation, equipment qualification, and method validation.
• Ensure validation documentation complies with regulatory guidelines.

6. Investigation and CAPA Management

• Lead investigations for deviations, OOS, complaints, and product recalls.
• Conduct root cause analysis and implement Corrective and Preventive Actions (CAPA).
• Monitor effectiveness of implemented CAPA.

7. Documentation and Data Integrity

• Ensure all quality documents comply with Good Documentation Practices (GDP).
• Control issuance, revision, and archival of SOPs, protocols, reports, and records.

8. Training and Team Management

• Provide GMP and quality system training to employees.
• Manage and supervise QA and QC teams.
• Ensure staff competency and skill development.

9. Vendor and Material Quality Management

• Approve and qualify vendors and suppliers.
• Ensure proper testing and release of raw materials and packaging materials.

10. Product Release

• Final batch review and release of finished products for distribution.
• Ensure products meet quality specifications and regulatory standards.

11. Customer Complaints and Market Surveillance

• Handle product complaints and adverse quality reports.
• Conduct product recall procedures when necessary.

12. Continuous Quality Improvement

• Monitor quality metrics and trends.
• Implement quality improvement initiatives to enhance product safety and compliance.

PPC (Production Planning & Control) Roles & Responsibilities

• Prepare monthly, weekly, and daily production plans based on sales forecasts and customer demand.
• Coordinate with production, warehouse, QA/QC, and procurement departments to ensure smooth production operations.
• Monitor availability of raw materials and packing materials for uninterrupted production.
• Plan and schedule manufacturing and packing activities according to production capacity and priorities.
• Ensure timely release of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for production.