Senior Validation Officer
6 days ago
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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