Amol Jadhav
LS Regulatory Compliance and CSV, Migrations, QA
- Role
- Business Architecture Team Lead at Accenture in India
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Amol Jadhav
Having more than 15+ yrs of software industry with skills of Computer System Validation…
Experience
Business Architecture Team Lead
Apr 2021 — Present · Pune, IN
Plans and coordinates validation activities in synchronization with project scope, schedule, and objective.• Responsible for ensuring the validation documentation and procedures are compliant with internal and external regulations and guidelines.• Regulatory compliance as per U.S. Title 21 CFR Part 11/210/820 Regulation, EU GMP Annex 11, ISO13485.• Responsible for authoring and signoff of validation lifecycle deliverables from GxP/System assessment, Validation Plan to Validation Report.• Preparing Validation Plan, Validation summary report, GxP Assessment, IQ, QO, and PQ protocol for various GxP and non-GxP projects by following Good Documentation Practices (GDP).• Review URS, Business process documents, Gap Analysis, and Risk Assessment.• Familiar with Verification and Validation (V&V), System categorization as per GAMP 5, and data integrity guidelines as well as Vendor Management, Defect Management, Deviation Management, Change Management, Corrective and Preventive Action (CAPA).• Familiar with Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC), Test case authoring, review, and evidence verification in MF-ALM. Also well familiar with the Scrum framework of Agile methodology. Team Management.
Education
Dr. M.G.R. Medical University, Chennai
M.Pharm., Pharmaceutical Analysis
2007 — 2009
Sant Gadge Baba Amravati University, Amravati
B.Pharmacy, Pharmaceutical Sciences
2003 — 2006
Skills
- Pharmaceutical Industry
- Sop
- Lc-Ms
- Life Sciences
- 21 Cfr
- Assay Development
- Maldi-Tof
- Pharmacovigilance
- Gmp
- In Vivo
- In Vitro
- CRO
- Biotechnology
- Q-Tof
- Validation
- Mass Spectrometry
- Glp
- Ba/Be Studies
- Metabolite Identification
- Toxicokinetics
- Gamp
- Good Laboratory Practice (Glp)
- Hplc
- Computerized System Validation (Csv)
- Software Testing Life Cycle
- Bioanalysis
- Drug Discovery
- Lifesciences
- Adme
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