SHARAD TAPASE

Result-driven and self-motivated individual seeking to contribute effectively to a dynamic organization, while continuously learning and enhancing my skills to achieve professional growth and excellence.

Validation, QMS, Green field Project, , CSV, Upstream, Sterile mfg,Fill Finish, eBMR.

• TGA, Australia
• CDSCO, MHRA, UK
• WHO-UNICEF
• ANVISA
• MCC
• USFDA

• 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)

Runner in ‘National level Quiz competition’ organized by K.B.P College of Engineering.

314, Malhar Peth, Satara, 415 002

• Hands-on experience developing and executing validation documents including IQ, OQ, IOQ, PQ & Summary reports.
• Lead execution of all aseptic and process validation functions and provide guidance and assistance regarding execution to validation engineers and technicians.
• Experience in validation deliverables like URS, P&IDs, FAT, SAT, generation & execution, etc
• Familiar with Quality Systems (Example: CAPA, Change Control, Deviation, Risk Management etc)
• Involve in cleaning validation, area qualification & equipment validation with risk assessment study.
• Experience in validation deliverables like URS, P&IDs, FAT, SAT & CSV protocol generation & execution, etc
• Involve in New SOP preparation & qualification protocol preparation.
• Actively involved in project work like FAT, SAT, SCADA & CSV qualification.
• Experience in executing pre-commissioning activities like walkdown, mechanical completion& assist in clean utility qualification.
• Operational & Performance Verification of process tank, Autoclave, Vial washing & Tunnel Depyrogenation, filling line.
• Involved in internal audits as per schedule. Preparation, review and compliance to various regulatory audits.

• Father's Name: Late Ashok T. Tapase
• Date of Birth: 12/17/87
• Nationality: Indian
• Marital Status: Married

10.10 lakh per annum.

Creative and Innovative, team player

Marathi, Hindi, English

Reading, playing cricket, Playing Chess.

I hereby solemnly declare that information furnished above is true to best of my knowledge and belief.