Executive / Sr. Executive – Quality Assurance & Compliance

1. Vendor & Third-Party Compliance

• Evaluate and approve third-party manufacturers, packers, and suppliers.
• Ensure all vendors comply with WHO-GMP / Schedule M requirements.
• Coordinate for vendor audits and maintain audit reports and CAPA tracking.

2. Product Quality Assurance

• Review and approve COA (Certificate of Analysis), BMR/BPR (where applicable), and release documents from manufacturers.
• Ensure products released to market meet defined specifications.
• Monitor batch traceability and documentation.

3. Regulatory & Documentation Control

• Maintain product dossiers, technical documents, and regulatory files.
• Ensure label claims, packaging materials, and promotional inputs comply with DCGI/FSSAI guidelines (as applicable).
• Control and update SOPs, quality manuals, and policies.

4. Market Complaints & Pharmacovigilance Support

• Handle product complaints from the field.
• Coordinate with manufacturers for investigation and closure reports.
• Maintain complaint registers and trend analysis.
• Support adverse event reporting (if applicable).

5. Distribution & Supply Chain Quality

• Ensure proper storage and distribution practices (GDP compliance).
• Monitor temperature-sensitive product handling.
• Conduct checks on C&F agents and stockists.

6. Internal Compliance & Training

• Conduct internal audits across departments.
• Train sales and marketing teams on compliance, product handling, and ethical promotion practices.
• Ensure adherence to company SOPs and industry standards.

7. Artwork & Promotional Material Review

• Review product labels, visual aids, and marketing materials for compliance with regulatory norms.
• Ensure no misleading claims are used