Harshit Pandey
Senior Executive QA/RA | Medical Device Quality Assurance Specialist | Regualatory Affairs Specialist
- Role
- Senior Executive Qa Ra at Datt Mediproducts Pvt. Ltd.
- Location
- Gurugram, IN
- LinkedIn followers
- 500 followers
About Harshit Pandey
Hello all, I have more than 3.8 years of rich experience in different medical device manufacturing in QA/QC as well as in RA Department. Want to grow up my career in QA/RA department. I am eligible to handle a team and i have good knowledge about QC/QA and RA department. Looking for an opportunity where i can implement the things which i have learnt and make company groww.
Experience
Senior Executive Qa Ra
Feb 2024 — Present · Gurugram, IN
PROCESS VALIDATION and IQ, OQ, PQFailure mode effect analysis for process (FMEA)Training managementGSPR- general safety and performance reportGap Analysis CDSCO licensing knowlegde and done application with CDSCOKnowledge of making DMF, Design file etc.Supplier audit and supplier selectionDose audit report and dose mappingSupplier agreement and evaluation Calibration handling and traceability Clean rooms validation handling Product technical specs QMS Documentation and customer complaints Data Analysis Device master file (DMF)Internal Audit and MRMExternal audit faced like MDSAP, KOREAN GMP, ISO13485:2016, ISO9001:2015
Education
Government polytechnic college - kashipur uttarakhand
Diploma in engineering
2017 — 2020
Ganga Institute of Technology & Management
Bachelor of Technology - BTech
2020 — 2023
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