Qualified new suppliers, managed Quality Agreements and coordinated with the global team to track audits for suppliers.Performed vendor Risk assessments, Periodic Reassessments and ensured Vendor Quality OversightPerformed investigations and proposed CAPA for deviations identified at the site.Site administrator for management of Document system using digital system.Conducted site self-audits to monitor cGMP implementation, identified risks and proposed CAPA for risk mitigation in coordination with subject Matter Experts.Performed gap analysis of SOPs against global Pfizer Quality Standards and local regulatory requirements.Conducted training sessions and managed human resource development to meet business needs.Managed Regulatory licensing processes including Test Licenses and Commercial product permissions from Directorate of Food & Drugs Administration.Attained renewal of regulatory certificates for drug manufacturing and distribution.Reviewed site changes impacting regulatory filings and submitted Post approval notifications to the Directorate of Food & Drugs Administration.Coordinated with cross-functional departments to obtain data for Regulatory submissions.

Performed review and approval of artwork for pharmaceutical products, ensuring Quality and regulatory compliance.Assisted in preparation of Annual Product Review records, analyzed data trends, and collaborated with SMEs to identify CAPA for quality improvements.Prepared and reviewed Batch Manufacturing Records and related manufacturing documents for GMP compliance.Initiated change controls for GMP change implementation.

Attained knowledge in QMS systems including Analytical method validation, Stability study, Raw materials and Finished product specifications.Ensured compliance with Data Integrity standards in every operation performed at the site.