Qualification Lead - IT/OT

Qualification Lead Role:

·       Primary focus is to ensure that the qualification of the OT system, quality management for IT and OT systems, ensuring that the required validation / qualification deliverables are implemented according to the Customer Quality Manual and the relevant regulatory requirements

·       According to the Customer procedures, author, review and/or approve various validation / qualification deliverables

·       Review / approve validation / qualification deliverables as provided by the supplier of the relevant system(s), ensure that such deliverables are compliant to the Customer requirements

·       Lead the project test resources in relation to the validation / qualifications related activities of the project

·       Act as the project’s quality representative in relation to testing activities, engaging with local site QA and/or QA eCPL

·       Report on the status of the various quality-related activities for key stakeholders

·       Engagement with the suppliers to advise the suppliers on the suitable completion of supplier provisioned validation / qualification deliverables.

Required Validation Activities

• Qualify IT/OT systems per Customer Quality Manual.
• Author, execute and review URS, FS, IQ, OQ and test protocols in Kneat.
• Perform test execution, troubleshooting and defect resolution.
• Review supplier deliverables and verify compliance.
• Coordinate with QA, PCM, ITOT teams and suppliers.
• Participate in FAT, SAT, commissioning and startup activities.

Desired Experience Profile

The candidate profiles proposed for this RFP emphasize:

• Strong CSV/CQV experience.
• GMP-regulated pharmaceutical manufacturing background.
• GAMP 5, EU GMP Annex 11, 21 CFR Part 11 knowledge.
• Experience with PLC, SCADA, DCS, MES, Historian, and IT/OT systems.
• Hands-on IQ/OQ/PQ execution and FAT/SAT support.
• Experience using Kneat, ValGenesis, Veeva Vault, TrackWise, ServiceNow or similar validation platforms.