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.

1. 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.

1. 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.

1. 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.

1. Validation and Qualification

- Oversee process validation, cleaning validation, equipment qualification, and method validation.

- Ensure validation documentation complies with regulatory guidelines.

1. 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.

1. Documentation and Data Integrity

- Ensure all quality documents comply with Valuable Documentation Practices (GDP).

- Control issuance, revision, and archival of SOPs, protocols, reports, and records.

1. 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.

1. Vendor and Material Quality Management

- Approve and qualify vendors and suppliers.

- Ensure proper testing and release of raw materials and packaging materials.

1. Product Release

- Final batch review and release of finished products for distribution.

- Ensure products meet quality specifications and regulatory standards.

1. Customer Complaints and Market Surveillance

- Handle product complaints and adverse quality reports.

- Conduct product recall procedures when necessary.

1. 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.

📌 Head Quality Control & Quality Assurance (Bhiwadi)
🏢 Zuche Pharmaceuticals
📍 Bhiwadi