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Senior Validation Officer

2 months ago

Morpeth, Northumberland, United Kingdom Piramal Pharma Solutions Full time
About the Role

Piramal Pharma Solutions is seeking a highly skilled Senior Validation Officer to join our team. As a key member of our Computerized Systems Validation (CSV) team, you will be responsible for ensuring the management of on-site CSV activities, with a focus on GxP computerized systems.

Key Responsibilities
  • Manage Computerized System Validation: Oversee the validation and re-validation of GxP IT systems, including HMI/PLC/SCADA/DCS/SaaS/IaaS, to ensure compliance with regulatory requirements.
  • Develop and Maintain CSV Project Plans: Create and update project plans and status tracking to ensure timely delivery of validation activities.
  • Review and Approve CSV Deliverables: Review and provide inputs on CSV deliverable documents received from vendors or prepared by internal IT/Quality teams.
  • Support Digitization and Automation Projects: Participate in and lead digitization and automation projects for site quality/IT/manufacturing processes.
  • Participate in IT Supplier Audits: Participate in IT supplier audits and FAT of equipment/instruments used in GxP environments.
  • Manage Computerized System Inventory: Manage the inventory of GxP systems at the site.
  • Ensure Compliance with Regulatory Requirements: Ensure compliance with 21 CFR Part 11 and EU Annex 11 for IT systems.
  • Participate in Data Integrity Assessments: Participate in data integrity assessments across the site, providing CSV input.
  • Participate in Quality Risk Management: Participate in quality risk management, including gap analysis and remediation planning for GxP IT systems with site quality.
  • Act as Subject Matter Expert: Act as the subject matter expert for CSV projects, guiding and training site IT teams on CSV, data integrity, and regulatory IT compliance activities.
  • Review IT-Related QMS Documents: Review IT-related QMS documents, such as change control, deviation, incidents, SOPs, etc., and provide inputs for CSV.
  • Closure of IT/CSV-Related Issues: Ensure timely closure of IT/CSV-related change control, deviation, incidents, CAPA, observations at the site.
  • Continuous Improvement: Participate in continuous improvement initiatives within quality.
Requirements
  • Keep abreast of changing regulations and industry expectations.
  • Maintain systems in line with regulatory requirements.