Pawar Satish Kumar

About Pawar Satish Kumar

Myself P. Satish Kumar, Iam M pharm graduate (Pharmaceutical analysis & Quality…

Experience

1. Senior Executive

   Biophore India Pharmaceuticals Pvt. Ltd

   Nov 2024 — Present

   Responsible for review and approval of Formulation Development Documents, a) Formulation Development Reports ( LNB & PDR ).b) Bill of Materials Quantities, Batch Manufacturing Records, Scale-up Manufacturing Records, Proposed Specifications, Master Formula Records, Master Packaging Records, Filter Validation Documents.c) Technology Transfer Protocol, Technology Transfer Reports.d) Study plans related to Stabilities, Hold time, Freeze thaw, Drug Device Compatibility, Inkwash study, Syringe compatibility study etc,2. Responsible for review and approval of Formulation Analytical Development Documents.a) Analytical Development Reports ( LNB & MDR)b) Method Validation Protocol and Reports.Tentative MOA\'s, Specification and Standard Test Procedures.c) Method Transfer Protocol and Reports.3. Review of Plant Manufacturing Documentsa) Batch Manufacturing Records.b) Batch Packing Records.c) Process Validation Protocols & Reports.d) Hold time Protocols and Reports.4. Review and approval of Change controls, Incidents, Laboratory Events, Document Ratifications and Document Correction Control Forms.5. Responsible for review and approval of Equipment Qualification documents, R&D Investigations, Risk Assessments ( Elemental impurities, Nitrosomine impurities and Residual Solvents) and Plant Queries ( OOS & OOT).6. Providing Line Clearance for Manufacturing area.7. Responsible for ensuring GMP/GLP/GDP compliance in Formulation and Analytical areas as per respective SOP\'s.8. Responsible for conducting Internal Audits/ External Audits for cross functional department\'s in Formulation division and External division.9. Responsible for review and approval of Vendor Qualification.10. Issuance, retrieval, distribution and archival of documents.11. Responsible for carrying out training (Induction training, new employee SOP training, Good documentation practice training etc,)

Education

• Osmania University

  M. Pharmacy

  2017 — 2019