Nitin Gadekar

About Nitin Gadekar

I\'m a highly driven pharmaceutical professional with a rich background spanning nearly a decade in the realm of Quality Management and Regulatory Compliance. My expertise encompasses a wide array of areas, including Change Control, CAPA, Manufacturing & Market Complaint Investigation, Product Recall, FAR, Audit & Compliance, APQR, Vendor Management, Tech.Transfer, Risk Management, Quality Operations, and Regulatory Compliance. Pharmaceutical Expertise:Throughout my career, I\'ve successfully led and contributed to a variety of projects, ranging from TrackWise and Documentum Implementation to retrospective assessments of deviation, market complaints, product assessments, and Control Sample evaluation. I\'ve been instrumental in the implementation of new SOPs and guidelines, ICHQ3D, NMDA Impurity risk assessments, Excipient risk assessments, and staying up to date with Pharmacopeia updates. International Exposure:I\'ve taken my skills global by conducting international API KSM vendor audits, including visits to manufacturing sites in Hilar and Shenyang, China. This exposure has enhanced my ability to navigate the diverse landscape of pharmaceutical manufacturing and compliance. Analytical Prowess:My background includes experience in pre-formulation, formulation development, and bio-analytical & analytical method development. I\'ve successfully developed and validated analytical methods for various drug molecules in blood and rat plasma, contributing to the precision and quality of pharmaceutical products. Regulatory Acumen:I\'m well-versed in the regulatory requirements of the US, Europe, Canada, and South Africa. My experience includes handling new product filings, addressing regulatory queries and responses, and conducting GxP assessments of computerized systems to ensure compliance with international standards. Projects of Note:FDA Remediation, retrospective evaluation of Investigation, and product evaluationPharmaceutical Quality System (PQS) Development & Implementation Corporate Policy and GovernancePharmacopeia Update, Implementation of ICHQ3D, Risk evaluation of NMDA Impurities, and Risk assessment of Excipients.Reduce/Skip testing program for API, Excipient In-process and finished products

Experience

1. Qms and Audit Compliance

   Crescent Pharma Ltd

   Mar 2021 — Present · 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.

Education

• Shri Shivaji Mahavidyalaya,Barshi.

  HSC

  2006 — 2008

• Modern College of Pharmacy,Pune

  B.Pharm

  2008 — 2011

• Birla Institute of Technology and Science

  Master of Pharmacy

  2011 — 2013