Description
A major Biotechnology / Pharmaceutical organisation based on the Cambridgeshire / Suffolk border has a fantastic opportunity for a QA SAP Specialist to join the team. You will be providing Computer Systems Validation support to a multi-functional team implementing SAP.Key Responsibilities
-Overall responsibility for the validation of the SAP implementation
-Work with corporate groups to perform and document risk assessments
-Support the SAP Team in the execution of User Acceptance Tests (OQ)
-Support any site based risk assessments
-Support in the development of SOPs and site based training.
-Develop test scripts for areas
-Review and approve corporate issued documentation (including User Acceptance Tests) to ensure that meets regulatory requirements and site needs.
Knowledge, Skills and Experience Required
-Extensive Computer Systems Validation experience.
-Prior experience of implementing and validating Enterprise Systems in to a site.
-Good knowledge of GAMP5 and a Risk Based approach to validation.
-Good understanding of regulation including EU Annex 11, 21 CFR Part 11 and 21 CFR 211.
-Work closely with the site team to support the site implementation of the global roll out of SAP.
-Build good relationships with the corporate groups, to ensure that the sites requirements are met.
-Communicates verbal and written information in a clear and accurate manner.
-Be able to work unsupervised to meet team objectives.
-Organises time effectively and prioritises tasks according to their urgency and/or importance
Please apply today with a covering letter highlighting your key skills and relevant experience aligned to this contract opportunity.