Sandip Kotarwar
Consultant at Biogen, Ex-Lupin, Ex-DRL, Ex-Cipla #GxP #21CFRpart11 #EUANNEX 11 #GAMP5 #AGILE #V-MODEL #QMS #Riskassessment #lifescience #DefectManagement #ChangeManagement #SDLC #Scrum #Agile #CloudComputing #ALM
- Role
- Csv Consultant at Biogen
- Location
- Nagpur, MH, IN
- LinkedIn followers
- 500 followers
About Sandip Kotarwar
As a CSV Consultant, I specialize in managing Computerized System Validation (CSV) projects for Life Science applications at Biogen. My primary focus is ensuring compliance with GAMP5, 21 CFR part 11 and EU ANNEX part 11 regulations. With a strong foundation in risk management and CSA, I collaborate with cross-functional teams to align software life cycle development with regulatory standards. Backed by over five years of experience in CSV at Osprey Software and Lupin and prior roles, I have developed proficiency in managing defect and change processes, risk assessments, and audit compliance. My goal is to enhance efficiency and compliance in dynamic environments while driving quality and safety standards within life sciences organizations.
Experience
Csv Consultant
Oct 2025 — Present · US
IT Quality person, Executed and managed CSV projects related to Life Science applications at Osprey Life Science LLC, ensuring compliance with EU ANNEX part 11, PICS and 21 CFR part 11. • Collaborated with cross-functional teams to align software life cycle development with regulatory standards. • Developed and implemented strategies to enhance project efficiency and compliance in a dynamic startup environment.
Education
S.S.P.I.D.P.
D. Pharm., Pharmaceutical Sciences
2006 — 2008
SKB College of Pharmacy
M.Pharmacy, Quality Assurance
2011 — 2014
VDHS nagpur
SSC, Sciences
1998 — 2004
SKB College of Pharmacy, Kamptee
Bachelor of Pharmacy - BPharm, Pharmacy
Skills
- Quality Assurance
- Auditing
- Gmp
- Disintegration
- Pharmaceutics
- Ipqa
- Formulation
- Gcp
- Hplc
- Cleaning Validation
- Pharmaceutical Industry
- Sop
- Fda
- Refractometer
- Crfs
- Change Control
- Bmr
- Ir
- Glp
- Circular Dichroism
- Calibration
- Dissolution
- Uv/Vis
- Deviation Control
- Karl Fisher
- Pharmaceutical Research
- Validation
- Gc-Fid
- Capa
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