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