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Senior CSV Officer

2 months ago

Morpeth Northumberland, United Kingdom Piramal Pharma Solutions Full time

JOB OVERVIEW: ​

The Computerised Systems Validation (CSV) has responsibility for the management of on-site CSV activities, with a significant focus on GxP computerised systems.​

Leading the CSV for GxP computerized systems, provide guidance, training to the site and ensure on schedule delivery of validation activities while managing vendor resources. To support in drafting of CSV artifacts, review and approval.

​

The role requires excellent coordination with clear and adaptable communication with external and internal stakeholders, such as Vendors, Clients, Quality, Project Management, Operations and Purchasing.​

Key Responsibilities:​

  • Manage Computerized system validation / re-validation and Infrastructure qualification activity for all GxP IT systems (HMI/PLC/SCADA/DCS/SaaS/IaaS etc).
  • Preparation and maintaining CSV project plan and status tracking.
  • Review of CSV deliverable documents received from vendor or prepared by internal IT / Quality team and provide inputs.
  • To support and lead Digitization and automation projects of site quality / IT / Manufacturing processes where required.
  • To participate in IT supplier audit and FAT of Equipment’s/ Instruments used in GxP environment at site.
  • To manage Computerized system inventory at site for GxP systems.
  • To support/ ensure 21 CFR Part 11 and EU Annex 11 compliance at site for IT systems.
  • Actively participate in Data Integrity assessments across the site, providing CSV input.​
  • Actively participate in Quality Risk Management, including gap analysis and remediation planning for GxP IT systems with Site Quality.​
  • Act as the Subject Matter Expert for CSV projects.​ To guide and train Site IT teams for CSV, Data Integrity and Regulatory IT Compliance activities.
  • Review of IT related QMS documents e.g. Change control, Deviation, Incidents, SOPs, etc. as applicable in various capacity. Provide inputs for CSV.
  • Timely closure of IT / CSV related Change control, Deviation, Incidents, CAPA, Observations at site.
  • Constructively challenge deficiencies and inefficiencies.​
  • Support non-CSV validation activities when required, including:​

Facilities​

Utilities​

Processes​

Systems​

  • Keep abreast of and maintain systems in line with changing regulations and industry expectations.​
  • Participate in continuous improvement initiatives within Quality.