Senior Validation officer

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