Rahul Nerkar
Associate Manager at Biocon Biologics
- Role
- Associate Manager at Biocon Biologics
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Rahul Nerkar
Experience in Operation compliance & Computer System Validation Planning for Life science…
Experience
Associate Manager
Jun 2021 — Present · Bengaluru, IN
Ensured end-to-end compliance to GxP computer systems as per FDA title 21 CFR part 11, 210, 211, ALCOA+ and GAMP5 guidelines for multiple projects including Master Data Quality, E-doc repository.Excellent Knowledge and experience in Good Documentation Practices. Abundant experience in authoring and reviewing Computer Systems Validations (CSV) Deliverables according to 21 CFR Part 11 and FDA regulations for the pharmaceutical industries.Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, System operation VP, VSR, SOPs, Protocol, URS, FS, Risk Assessment, Decommission report, Periodic Review Report.Ability to meet the timelines and guide the stakeholders as an independent role.Confident in dealing with stakeholders, Project Management, Good Communication, Writing Skills, Fluent in English.
Education
Sanjivani college of P'ceutical Res. & Edu. Kopargaon
B.Pharmacy, Pharmacy
2005 — 2009
Skills
- Biotechnology
- Manufacturing
- Sterilization
- Gmp
- Sop
- Validation
- Pharmaceutical Industry
- Biopharmaceuticals
- Lifesciences
- Fda
- Quality System
- Capa
- Aseptic Processing
- Change Control
- Life Sciences
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