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Senior Validation officer

30+ days ago 2026/05/07 Expires in 3 days
No experience required
Other Business Support Services
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Job description

Key Responsibilities


  • Plan & execute Computer System Validation (CSV) activities in compliance with GMP, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
  • Perform and support Data Integrity (DI) assessments and remediation activities in QC laboratories and manufacturing environments.
  • Participate in and lead data analysis, gap assessments, and risk assessments related to CSV and DI.
  • Support qualification activities including IQ and OQ (Equipment , system and utilities qualification knowledge for sterile and non-sterile manufacturing is advantage)  
  • Prepare, review, and approve CSV documentation such as URS, FS/DS, Risk Assessments, Validation Plans, Protocols, Reports, and Traceability Matrices.
  • Support validation and ongoing compliance of computerized systems including:
    • LIMS
    • eQMS
    • SAP and related modules
  • Ensure validated systems remain in a state of control through change management, periodic reviews, and incident management.
  • Collaborate with QC, Manufacturing, IT, Engineering, and external vendors during system implementation and upgrades.
  • Support regulatory inspections and audits (EU, FDA, and other health authorities).
  • Mentor junior CSV engineers and contribute to continuous improvement initiatives.
  • Plan and perform data flow map in different system specially in library environments
This job post has been translated by AI and may contain minor differences or errors.

Preferred candidate

Years of experience
No experience required
Degree
Bachelor's degree / higher diploma
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