Udaykumar Kashid
Senior Research Officer at Glenmark pharmaceuticals ltd || Computerized System Validation || Analytical Research and Development
- Role
- Senior Research Officer at Glenmark Pharmaceuticals Ltd at Glenmark Pharmaceuticals
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Udaykumar Kashid
Analytical Research and Development
Experience
Senior Research Officer at Glenmark Pharmaceuticals Ltd
Jul 2021 — Present · Mumbai, IN
In GxP (GLP and GMP) environment, development of validation documents for equipment and their computerized systems. Preparation, execution and Review of CSV deliverables. Preparation of validation plans, specifications, test protocols and SOP. Preparation, execution and Review of Computerized System Validation documents like URS, IQ, OQ, PQ as per 21 CFR Part 11, GAMP 5, EU Annexure 11, etc. Regulatory compliance and Quality management requirements. Internal-External (Regulatory) audits, Audit reports, Audit compliance.Preparation of validation plans, specifications, test protocols and SOP. Knowledge of GAMP 5, US FDA 21 CFR Part 11, and EU Annexure 11. Knowledge of V model, SDLC life cycle, etc.Experience in Regulatory compliance and Quality management requirements.Analytical method development, method transfer, method pre validation, routine and stability analysis for oral solid dosage forms, also for liquid injectable (peptide molecules).Preparation of STP, method development reports, method transfer protocol and reports, method validation protocol and reports. Review and Preparation of Empower software monthly audit trail reports. Resolve method related problems and issues in plant. Support QC for troubleshooting related to product.Handling, analysis and maintenance of control substances and its products. Following GMP, GLP and GDP in day to day activities in lab.Compliance, QMS, Audit trail, etc.
Education
Bharati Vidyapeeth's College of Pharmacy
M. Pharmacy (Quality Assurance)
2010 — 2012
Bharati Vidyapeeth college of pharmacy Kolhapur
M pharm
2010 — 2012
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