Nandisha A Ashok
CSV
- Role
- Assistant Manager at Solara Active Pharma Sciences
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Nandisha A Ashok
PROFESSIONAL SKILLS EXPERIENCE ON CSV RESPONSILIBILITIES: Good Understanding of CSV & 21 CFR Part 11/Annex 11, GAMP Guidance on IT infrastructure control and Compliances and related regulation & guidelines. Good understanding on GxP & ER/ES Assessment. Good Communication and Documentation skills. Planned and executed Qualification on activities as per the approved VMP as per GAMP 5, ISPE Qualification and Validation on Guidelines. Preparation, review and approval of validation deliverables like URS, GxP, ER/ES Assessment, VP, FS, CS, IQ, OQ, PQ, and RTM documents. Knowledge on V-Model Framework projects. Responsible for preparation and review of Validation master plan for Computerized Systems. Strong understanding of SDLC and CSV methodologies. Good knowledge on pharmaceutical lab procedure and latest regulated industry requirements. EXPERIENCE ON LIMS RESPONSIBILITIES: In-depth knowledge of FDA regulation 21 CFR Part 11 (Electronic Records, Electronic Signature, Audit Trails and Security events), GxP Regulations, GAMP 5. Experience with Laboratory Workflow and Quality Control principles. instrument interface with balance and pH meter. Details knowledge in sample workflow, Stability management, workflow master data creation to link with samples and to submit analysis. ANALYTICAL EXPERIENCE Analysis of Pharmaceutical Active, Stability Samples, Intermediates and Finished Products. Calibration of Quality Control Instrument Performance of OQ & PQ of new Quality control instruments like HPLC,KF-Auto Titrator,Balance and pH meter. Handling of Deviation, Laboratory Incidents, through TrackWise Application. Performing the Temperature and Humidity mapping of lab areas, Reserve sample room, Stability walk-in chambers, Reach-in chambers, Oven, Muffle furnace, and Laboratory freezers. Preparation of Protocol and report for the Temperature mapping activities. Having good knowledge in QMS system, cGMP, GLP and Knowledge of handling QMS documents. Coordinating with vendor and central engineering team for AMC, PM Activities of the instruments.
Experience
Assistant Manager
Mar 2023 — Present · Chennai, IN
computer system validation
Education
Jss university
Master's degree, Biochemistry
2014 — 2016
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