Senior Validation Officer

6 days ago


London, Greater London, United Kingdom Piramal Pharma Solutions Full time
Job Overview

The Computerized Systems Validation (CSV) team at Piramal Pharma Solutions has responsibility for the management of on-site CSV activities, with a significant focus on GxP computerized systems.

Key Responsibilities:

  • Manage the validation and re-validation of computerized systems, including infrastructure qualification, for all GxP IT systems.
  • Develop and maintain a CSV project plan and track status.
  • Review and provide input on CSV deliverable documents received from vendors or prepared by internal IT and Quality teams.
  • Support and lead digitization and automation projects for site quality, IT, and manufacturing processes.
  • Participate in IT supplier audits and FAT of equipment/instruments used in GxP environments.
  • Manage the computerized system inventory for GxP systems.
  • Ensure compliance with 21 CFR Part 11 and EU Annex 11 for IT systems.
  • Contribute to data integrity assessments across the site, providing CSV input.
  • Participate in Quality Risk Management, including gap analysis and remediation planning for GxP IT systems.
  • Act as a subject matter expert for CSV projects and guide and train site IT teams on CSV, data integrity, and regulatory IT compliance activities.
  • Review IT-related QMS documents and provide input for CSV.
  • Closure of IT/CSV-related change control, deviation, incidents, CAPA, and observations.
  • Constructively challenge deficiencies and inefficiencies.
  • Support non-CVS validation activities, including facilities, utilities, processes, and systems.

Requirements:

  • Stay up-to-date with changing regulations and industry expectations.
  • Participate in continuous improvement initiatives within Quality.

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