Nitin Gadekar

Qms and Audit Compliance @Crescent Pharma Ltd

Mumbai, IN

Auditing Proficiency: Conducts Internal, Contract Manufacturing Organization (CMO), and Active Pharmaceutical Ingredient (API) supplier audits, managing compliance tracking. Keeps abreast of proposed compliance. Successfully faced MHRA GMP, Two MHRA PV and third party/consultant audits. Inspection Readiness and Response: Takes charge of responding to Health Authority and Internal inspections, ensuring compliance through Corrective and Preventive Actions (CAPA). Acts as the primary contact during Health Authority inspections. Change Control and Compliance Oversight: Proficient in reviewing and approving Change Controls, Deviations, OOS/OOT, Market Complaints, and adept at tracking these processes in Master Control for EU, China and Indian CMOs. Collaborative Compliance Initiatives: Collaborates effectively with EPIC Consultants, Qualified Persons (QP), Responsible Persons for Import (RPi), and Qualified Person for Pharmacovigilance (QPPV) to achieve and maintain compliance with MHRA GMP and Pharmacovigilance standards. Regulatory Compliance and Gap Assessments: Skilful in reviewing and preparing GAP assessments for regulatory updates, ensuring timely implementation to meet compliance requirements. Document Management and Approval: Reviews and approves critical documents such as BMR, BPR, Product Quality Reviews (PQR), Process Validation Protocols/Reports, and Stability Protocols received from Contract Manufacturing Organizations (CMO). Data Management and Reporting: Proficient in data collection, conducting weekly and quarterly management meetings, and facilitating necessary escalations. QMS Implementation and Process Enhancement: Successfully implemented Quality Management System (QMS), enhancing processes, and closely monitoring commitments arising from audits. Pharmacovigilance Support: Actively involved in safety updates and providing support in Pharmacovigilance-related activities RMP, Educational Material, and Annual Reviews.

Modern College of Pharmacy,Pune

B.Pharm

Shri Shivaji Mahavidyalaya,Barshi.

HSC

Birla Institute of Technology and Science

Master of Pharmacy