About the role
Start Date: 04/02/2019
Estimated End Date: 30/06/2019
Location: M4 Corridor
Rate: £450 – £500
Department: SEQ – Global Quality Systems Maidenhead
Job Category: Quality
- Provide QA oversight and guidance for SEQIRUS computerized systems and processes, including the review and approval of GxP ERES Assessment, standards and documents for all GxP and non-GxP relevant systems related to the determination of GxP applicability.
- Review and approve global procedures (e.g., SOPs, Work Instructions) and all project related documents for all GxP relevant systems. This includes operational life cycle management documents and relevant infrastructure.
- Support the computer system validation of GxP systems to be utilized in the Brexit Amsterdam and other GxP based projects.
- Provide QA oversight and approval into deviations and investigations involving GxP Computerized Systems
- Review and approve scripts and testing and provide QA Oversight to testing strategies
- Support the delivery and approval of CSV life cycle documents
- At least 3-5 years of relevant experience with GxP-regulated responsibility in Biotech/Pharma industry working in computer system validation
- Strong understanding of the CSV life cycle in a regulated environment
- Strong skills in SAP, Lab systems and associated GxP systems
The ability to work independently and as part of a team and a positive attitude . You will have demonstrated effective decision making ability and key Stakeholder management skills.