Sharad Tapase
Bangalore
Summary
Result driven Biopharmaceutical Professional with 12+ years of experience in Aseptic manufacturing, Fill Finish, Document compliance includes Quality management systems (QMS), Commissioning, qualification and Validation, training, Harmonization of procedures & associated with documentation activities at upstream and downstream operations from multiproduct GMP facility.
Overview
18
18
years of professional experience
Work History
Sterile injectable,QMS, Validation,Production, training and Documentation - Fill Finish & Upstream
PlasmaGen Biosciences private Limited
01.2022 - Current
- Handling of change controls (Major /Minor), Deviations and CAPA & Investigating the manufacturing deviations and Discrepancies during validation related to fill finish department.
- Commissioning, qualification and validation of facility and process associated equipment's (Process vessels, steam sterilizer, cold room, Depyrogenation tunnel, Vial washing & filling & sealing machine.
- Management of training of employees in the manufacturing department (Initial and on-going training) and qualified trainer for fill finish department.
- Preparation of batch manufacturing & Media fill records (BMR & Checklists), SOPs, technical documents, study protocols, Validation Protocols, qualification documents for manufacturing &Fill Finish.
- Handling of risk assessments related to equipment, facility, process & procedures in fill finish department.
- Actively involved in project work like FAT, SAT, SCADA & CSV qualification.
Manufacturing Compliance - Upstream Manufacturing & Fill Finish
Reliance Lifesciences
07.2016 - 12.2022
- Handling of change controls (Major / Minor), Quality events (Incidents / Deviations) & CAPA for upstream and Fill Finish operations using TrackWise Application.
- Investigating the manufacturing deviations, Discrepancies during validation related in Fill Finish Area.
- Commissioning, qualification and validation of facility and process associated equipment's (URS, FRS, FAT, SAT, IQ, OQ, IOQ & PQ) from start-up to production - clean rooms (Grade B, C & D), Water systems (PW, PS & WFI), process equipment's (Bioreactor) Autoclave, process utilities, table top instruments, Cold room & lyophilizer.
- Preparation & review of validation documents for Fill Finish (URS, DQ, FAT, SAT, IQ, OQ, IOQ & PQ).
- Decommissioning of manufacturing equipment's and computerized systems & preparation of associated documents.
- Handling the complaints related to the materials supplied from the vendors in the manufacturing facility.
- Management of training of employees in the manufacturing department using SAP software.
- Tracking and scheduling of annual refresher training of employees involving in the manufacturing operations.
- Preparation of batch manufacturing records (BMR & Checklists) using e-BMR software.
- Preparation of SOPs, technical documents, study protocols, rationale documents, qualification documents & strategic documents for manufacturing using eDMS & eBMR(PAS-X) software.
- Handling of risk assessments related to equipment, facility, process & procedures for upstream and downstream manufacturing operations.
- Periodic review of risk assessment related to equipment, facility, process & procedures for upstream and downstream manufacturing operations & Trending of QMS elements.
- Management of Issuance and control of manufacturing documents for the execution of batch activities.
Compounding, Formulation & Fill Finish
Fresenius Kabi Goa
09.2014 - 06.2016
- Handling & monitoring Area like Water system, Compounding, Filling & Autoclaving.
- Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
- Audit Program Management and execution.
- Familiar with Quality Systems (Example: CAPA, Change Control, Deviation, Risk Management etc).
- Involve in Area qualification, cleaning validation, area qualification & equipment validation with risk assessment study.
Formulation & Fill Finish
Indoco Remedies Goa
08.2013 - 02.2014
- Monitoring of production activities likes vial Decartoning, Vial washing & vial depyrogenation, Aseptic liquid filling.
- Lyophilization activity like VLT, CIP, SIP, Operation recipe.
- Performance Verification of Autoclave, Vial washing & Tunnel Depyrogenation, filling machines and sealing machine.
- Involved in internal audits as per schedule. Preparation, review and compliance to various regulatory audits.
Formulation & Manufacturing
Mediorals Ltd.
11.2007 - 04.2010
- Dispensing of raw materials.
- Involve in batch manufacturing activity.
- Responsible for BMR filling & submission of Documents.
- Involved in internal audits as per schedule. Preparation, review and compliance to various regulatory audits.
Education
Bachelor in pharmacy -
Shivaji University
01.2013
Diploma in Pharmacy -
Govt. College of pharmacy
01.2007
Skills
- Track Wise
- EVLMS
- DMS
- ECSV
- LIMS
- SAP
- E-BMR
- Commissioning
- Qualification
- Validation
- Quality management systems
- Manufacturing operations
- CGMP
- GDP
- ISPE Volume 5
- GAMP 5
- 21 CFR Part 11
- EU Annexure 11
- USFDA
- ISO
- EN285
- WHO
- ICH Guidelines
- Investigating deviations
- Change control
- Corrective actions
- Preventive actions
- Preparation of documents
- Writing SOPs
- Reports
- Technical documents
- Study protocols
- Validation documents
Languages
Marathi
English
Awards And Seminars
- Reliance Employee Achiever, For excellent performance and accomplishment in 2021 as Employee of The Year.
- Revised SCHEDULE M Seminar, Attend Revised SCHEDULE M CDSCO Seminar at Bangalore in 2024.
- Pharma warrior award, For motivate employee & doing services at corona period.
Disclaimer
I, Sharad Tapase hereby declare that the information contained herein is true and correct to the best of knowledge and belief.
Equipment Qualification Handled
- Mfg. vessel(pharmalab, Adam, DDE, PRAJ)
- Filling machine (Bausch Strobel, romaco macofer, NKP)
- Centrifuge (GEA)
- Depyrogenation Tunnel
- Lyophilizer (Trueking, Lyovac)
- Autoclave (Icos, Sterdrill, Pharmalab)
- Water system (Pharma lab)
- BPT machine(sartorius, Merck)
- CIP Skid (sartorius, DDE)
Timeline
Sterile injectable,QMS, Validation,Production, training and Documentation - Fill Finish & Upstream
PlasmaGen Biosciences private Limited
01.2022 - Current
Manufacturing Compliance - Upstream Manufacturing & Fill Finish
Reliance Lifesciences
07.2016 - 12.2022
Compounding, Formulation & Fill Finish
Fresenius Kabi Goa
09.2014 - 06.2016
Formulation & Fill Finish
Indoco Remedies Goa
08.2013 - 02.2014
Formulation & Manufacturing
Mediorals Ltd.
11.2007 - 04.2010
Bachelor in pharmacy -
Shivaji University
Diploma in Pharmacy -
Govt. College of pharmacy
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