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

Duties:

  • 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
     

Skills:

  • 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.
 

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