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System Validation Qms Risk Management

Work Mode

On-site

Job Type

Full Time

Job Description

6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQs, TRM. Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation. Ensure GxP Computerized Systems are validated as per GAMP -5 requirements. Stakeholder management and good executor with required communication. Candidate must have fair conceptual understanding on below key areas IT QMS Validation/Qualification Risk management. Handling of defects/Deviations Investigations CAPA Handling Test Management & Compliance Candidate must have understating on latest regulations ie 21CFR Part 11, EU annex 11, and Guidelines eg GAMP5 guide. Candidate will provide an application validation expertise practically on different scenarios as applicable case to case ie, standalone/enterprise etc Desired/ Secondary skills Hands-on experience on testing tools like Client ALM, Kneat and SNOW Experience to MES, QMS (Trackwise), Lab solutions ie LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc will be an advantage OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus) Client/DCS Qualification ISA95 High level of understanding OT Security will be a plus. Standalone Systems Qualifications Client/DCS Integrated with Manufacturing Equipment qualification.

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