Bosontech IT Services Private Limited
Website:
bosontech.in
Job details:
We are Looking for Computer Validation System Engineer....
Experience : 7-10 years
Job location : Remote / WFH
Notice period : Immediate Joiner/ 15 days Notice preferred
Email : akash.sharma@bosontech.in
Job Description
- 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
- Authoring of URS/FS, protocols, final reports, validation plan/report
- High-level understanding of Veeva Vault suits
- Risk-based testing aligned to CSA fundamentalsHigh-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP
- High-level understanding of Veeva eQuality Suite, Labware LIMS, Skyland Analytics/Visualization tool, Biovia Electronic Lab Notebook
- High-level understanding of SAP GxP modules
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