Job Description

Job Description:

Support IT/OT system owners with computer system validation (CSV), lifecycle documentation, compliance reporting, and ongoing system maintenance for GMP-regulated manufacturing systems (ISA-95 Level 2 & 3).

Responsibilities:

  • Perform CSV/CSA lifecycle activities: validation, testing, documentation, and periodic reviews.

  • Create/update and execute validation protocols (IQ/OQ/PQ, test scripts, reports).

  • Support annual system maintenance (MILE) and system audits.

  • Manage QMS records (CAPA, Deviations, Planned Events).

  • Ensure GMP & data integrity compliance during system upgrades/changes.

  • Collaborate with system owners and global stakeholders.

  • Support document management systems and compliance reporting.


Mandatory Skills / Requirements: ...

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