Job Description:
GMP Compliance: Implement Positive 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 current 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.