Job Description
Job Description & Requirements
Job Purpose
To lead and execute end-to-end Computer System Validation (CSV) activities for DeltaV automation systems in pharmaceutical manufacturing, ensuring full compliance with GMP, 21 CFR Part 11, EU Annex 11, and PIC/S requirements.
Key Responsibilities
DeltaV Validation Lifecycle Leadership
Review and approve DeltaV Functional Specification (FS) and Design Specification (DS) for GMP-critical systems.
Prepare, execute, and approve validation protocols:
Software Installation Qualification (SIQ)
Input/Output (I/O) Loop Check Protocols
Functional/Design Qualification (FQ/DQ) as required
Conduct pre-execution and post-execution reviews of all CSV protocols.
Compliance & Documentation
Approve automation change controls, including risk assessments (GAMP 5, FMEA).
Ensure adherence to data integrity principles and electronic record/electronic signature (ERES) requirements...
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