Description
Validation Lead/Computer Systems Validation Specialist: Our client a global leading OTC and FMCG sector is currently looking for a Validation Lead or Computer Systems Validation Specialist. Reporting to the Senior Validation Manager this role will be primarily responsible for supporting SAP deployment, compliance planning and tracking of project deliverables.
- Authoring computer systems validation documentation, primarily plans and reports
- Review and approval of validation, testing, project and design documentation,
- Review and approval of change controls and associated documentation for SAP and IT systems.
Additional activities include providing validation support/guidance for new and current projects, quality and compliance reviews of project testing, ensuring adherence to processes within the global programme and compliance with all relevant standards, mentoring/training team members in GxP activities, support of release cycles.
Essential Skills
- Minimum 4-5 years demonstrable CSV experience within an IT change managed/controlled environment
- Previous experience working within a GxP regulated environment and an understanding of Pharma industry regulations
- Good understanding of the principles and process of change management in IT
- Change control review, approval and management - including associated testing.
- Good understanding of the principles of testing
- Ability to multitask and prioritise workload
- Quick to learn new processes and skills
- Good understanding of principles of a software development life cycle (SDLC)
- Good MS Office skills
Desirable Skills
- Experience with working within a fast-paced application development and delivery environment
- Mentoring/training delivery in relation to GxP process and good practice
- Any exposure to SAP, ClearQuest, Quality Center, EDMS systems (or other similar systems)
Other requirements include: strong business acumen and knowledge of companies' processes; effective collaboration skills; the ability to interact effectively with all levels of management; willingness to challenge the status quo and affect positive change; solid influencing and relationship-building skills; strong IT technical skills.