1. GMP Compliance: Implement Positive Manufacturing Practices (GMP) to ensure product
safety and quality throughout the lifecycle.
2. Documentation & SOPs: Develop, review, and maintain Standard Operating
Procedures (SOPs), batch records, and, in some cases, documentation for approvals or
exports.
3. Auditing: Conduct internal and external audits of manufacturing facilities.
4. CAPA & Deviations: Manage deviations, non-compliance issues, and implement
Corrective and Preventive Actions (CAPA).
5. Product Release: Ensure products meet required specifications before release.
6. Regulatory Filings: Prepare and submit dossiers for new drug applications.
7. Compliance Strategy: Monitor and interpret regulatory guidelines to ensure products
meet legal standards.
8. Liaison: Act as the primary contact between the company and regulatory agencies.
9. Will be responsible for DMF process.