Mahesh Varat
Senior Consultant @ Infosys | CSV, Risk Assessment, Product Quality Manager Certified Scrum Master
- Role
- Senior Consultant at Infosys
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Mahesh Varat
End to end Computer system validation, Self inspection, SDLC documentation (Validation…
Experience
Senior Consultant
Jan 2022 — Present · Pune, IN
Product Quality Manager Certified Scrum master Role on JIRA from Infosys -End to end Computer system validation/Assurance on ValGenesis, Self inspection, SDLC documentation (Validation plan, URS, DQ, PQ, IQ, OQ, process gap analysis, traceability matrix, Validation Report), 21 CFR part 11 and GAMP5 for H4 HANA system Validation Practices with a good understanding of GxP (GMP,GLP & GDP) standards and 21CFRPart 11. Hands on experience in JIRA,IBM Rational clearcase, Trackwaise. HPLC and GC software’s likeOpen LAB EZChrom, Chemstation, EMPOWER, Chromleon etc. Mentored the team for Quality, Compliance, and Good Documentation Practices. Extensively authored and reviewed, system life cycle documents such as IQ(Installation Qualification),OQ(Operational Qualification),Validation summary report, Impact Analysis, etc. Involved in client communication and interaction with business users. Good working knowledge of Validation, Manual, Functional testing in diverse applications underLife Sciences domain.
Education
University of Pune
M. Pharmacy
2007 — 2013
Laxman Narayan Hoshing Vidhyalaya Jamkhed
5 to 10
1997 — 2005
S.N.D College of Pharmacy Babhulgaon, Nashik
Bachelor of Pharmacy (B.Pharm.)
2007 — 2011
Padma Shri Doctor Vithalrao Vikhe Patil Science, Art and Commerce College of Pravaranagar (Loni)
11 and 12 Science
2005 — 2007
PDEA's Seth Govind Raghunath Sable College oF Pharmacy Saswad
Master's degree
2011 — 2013
Skills
- Hplc
- Analytical Methods Development
- 1h Nmr
- Ftir
- Formulation
- Pharmaceutical Industry
- Pharmacology
- Nmr
- Mass Spectrometry
- 13c Nmr
- Pharmaceutics
- Organic Synthesis
- Hplc-Ms
- Molecular Modeling
- Docking
- Uplc
- Chemistry
- Qsar
- Nmr Spectroscopy
- Pharmaceutical Process Development
- Drug Design
- R&D
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