Qualification Lead - IT/OT
About The Position
The Qualification Lead is responsible for qualification of OT systems and quality management for IT and OT systems, ensuring required validation and qualification deliverables comply with the Customer Quality Manual and applicable regulatory requirements. The role authors, reviews, and/or approves qualification deliverables, including supplier-provided documentation, and advises suppliers on completing those deliverables appropriately. The Qualification Lead leads project test resources for validation and qualification activities and acts as the project quality representative for testing, engaging with local site QA and/or QA eCPL. The role reports quality-activity status to key stakeholders and coordinates qualification work with QA, PCM, ITOT teams, and suppliers.
Requirements
- Strong CSV/CQV experience.
- Background in GMP-regulated pharmaceutical manufacturing.
- Knowledge of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
- Experience with PLC, SCADA, DCS, MES, Historian, and IT/OT systems.
- Hands-on IQ/OQ/PQ execution and FAT/SAT support experience.
Nice To Haves
- Experience using Kneat, ValGenesis, Veeva Vault, TrackWise, ServiceNow, or similar validation platforms.
Responsibilities
- Qualify IT/OT systems in accordance with the Customer Quality Manual.
- Author, execute, review, and/or approve validation and qualification deliverables, including URS, FS, IQ, OQ, and test protocols in Kneat.
- Review supplier-provided validation and qualification deliverables and verify they comply with Customer requirements.
- Lead project test resources for validation and qualification activities.
- Act as the project’s quality representative for testing activities, engaging with local site QA and/or QA eCPL.
- Report the status of quality-related activities to key stakeholders.
- Engage with suppliers and advise them on suitable completion of supplier-provided validation and qualification deliverables.
- Perform test execution, troubleshooting, and defect resolution.
- Coordinate with QA, PCM, ITOT teams, and suppliers.
- Participate in FAT, SAT, commissioning, and startup activities.
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What This Job Offers
Job Type
Full-time
Education Level
No Education Listed
