xperience 5 years of dedicated Computer System Validation (CSV) experience within the pharmaceutical| biotech| or medical device industries.Regulations Deep working knowledge of GxP (GMP| GCP| GLP) environments| 21 CFR Part 11| EU Annex 11| and GAMP 5 principles.Tools Proven experience utilizing Veeva Vault QMS| TrackWise| or highly similar corporate electronic quality management systems.Skills Expert proficiency in manual test script writing| data integrity principles (ALCOA)| and technical writing.GxP Systems Strong validationadmin experience in one of these systems in GxP setting and working familiarity with one or two systems ERP (SAPOracle)| MES| LIMS (LabwareStarlims)| eQMS (VeevaTrackwiseMaster Control) Education Bachelors degree in Computer Science| Bioengineering| Life Sciences| or a related technical discipline.
Essential Skills: Experience 5 years of dedicated Computer System Validation (CSV)
experience within the pharmaceutical| biotech| or medical device industries.Regulations Deep working knowledge of GxP (GMP| GCP| GLP) environments| 21 CFR Part 11| EU Annex 11| and GAMP 5 principles.Tools Proven experience utilizing Veeva Vault QMS| TrackWise| or highly similar corporate electronic quality management systems.Skills Expert proficiency in manual test script writing| data integrity principles (ALCOA)| and technical writing.GxP Systems Solid validationadmin experience in one of these systems in GxP setting and working familiarity with one or two systems ERP (SAPOracle)| MES| LIMS (LabwareStarlims)| eQMS (VeevaTrackwiseMaster Control) Education Bachelors degree in Computer Science| Bioengineering| Life Sciences| or a related technical discipline
📌 Computer System Validation (Noida)
🏢 TCS_India
📍 Noida
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