Nitin Kashyap Email and Phone Number

§ CSV Projects Management: Identified project & system specific risks, developed, authored & reviewed validation deliverables such as GxP Risk Assessment, ERES, Validation patterns, Validation Plan & Report, Traceability Matrix, Data Migration Plan & Report, URS, FRS, IQ, OQ, PQ etc.§ Operation Quality Management: Developed, Implemented, trained and supported QMS (Change Management, Incident & Deviation Management, Problem Management, CAPA implementation & Effectiveness check) through TrackWise & ServiceNOW applications. Conducted risk based periodic review of GxP Systems by routinely monitoring indicators of performance, identified trends & implemented appropriate actions.§ Stakeholder Management & New proposal handling: Liaised with Stakeholders independently and continued progressive relation in achieving mutual goals & expectations. Involved in Request For Proposals (RFPs) for new proposals in Pharma, Healthcare/Medical Devices domains for CSV processes & service offerings. Involved in Quality Governance for effective compliance.§ Training Management: Developed training cum Certification on CSV, trained new joiners periodically on CSV concepts & processes, GAMP5, OQM activities and facilitated in QMS adoption.

Audit Compliance & Support: Proficient with CSV Gap Analysis, 21 CFR Part 11 assessment, FDA Part 820 Controls, PIC/S, EU Annex 11, GxP, GAMP5, Access Control & Password Management, Verifying Audit Trials, Risk Management, Data Integrity and supporting Internal, Regulatory & Customer audits.Quality Management Systems: Handling of QMS activities such as Change Management System, Incidents, Deviations & CAPA implementation & Effectiveness check through Trackwise application & Training Cross Functional Teams for the same.R&D Projects Support: Online tracking of projects along with efficient planning for timely product launch; Monitoring & networking with Cross functional teams and with customers for timely closure of projects.Qualifications Support: End to end preparation, execution & verification of qualification protocols (DQ, IQ, OQ, PQ) for all concerned instruments/equipments, systems, facilities & utilities in order to validate its compliance to design, installation, operation and performance across SDLC.Product development activities Review & Compliance: End to end review of development activity documents & ensuring compliance until Scale Up; SOP review & compliance checks.Third Party Quality Support: Operational Support to Mylan third party Sites.

Audit Compliance & Support: GxP rounds; preparing and facing customer, internal & regulatory audits.Quality Management Systems: Support in Incident & Investigations, Complaints, CAPA, and Change Management SystemQualification Support: Support in end to end execution of Qualification (DQ, IQ, OQ, PQ) activities and Verification of compiled reports.Monitoring of critical development activities: End to end monitoring & inspection of development activities.Medical Device Market Complaints management: Handling of Medical Device market complaints for Biocon & Mylan Global.Handling of Master Documents: Issue/review/approval of Master development documents and review of SOP, Validation Protocols & Reports & other QA related documents.Employee Training: Training students/new joiners, working employees on QA activities & GxP Compliance.

Process Development for Technology Transfer of a Herbal Formulation