Job Reference: J5631804
Updated On: 02/07/2019
Status: Open to Applications
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Role OverviewThis is an opportunity for an experienced Computer Systems Validation (CSV) / Quality Assurance Consultant to join an innovative Pharmaceutical organisation in Japan.
As the Senior CSV Consultant you will be responsible for providing Quality Assurance review and approval of CSV / SDLC deliverables within a Pharmaceutical environment for a global SAP platform.
Key Duties and ResponsibilitiesYour duties as the CSV Consultant will be varied however the key duties and responsibilities are as follows:
1. You will provide Quality Assurance Review and Approval of Computer Systems Validation (CSV) / Software Development Life Cycle (SDLC) deliverables in a timely manner.
2. Your primary role will be providing expertise for GxP aspects of the Global SAP Platform (System/Application), Infrastructure, solution manager, test management and training tools as well as GxP interfaces.
3. You will participate in project meetings, and evaluate issues to the Project Lead for the SAP Platform as necessary.
4. You will be responsible for assessing Vendors and Service Providers for GxP Compliance, SDLC/CSV, including Good Automated Manufacturing Practice (GAMP5) and establishing Quality Agreements as necessary.
Role Requirementso be successful in your application to this exciting opportunity as the CSV Consultant we are looking to identify the following on your profile and past history:
1. Relevant degree or equivalent
2. Proven industry experience in the Pharmaceutical industry is essential.
3. A working knowledge and practical experience with SAP / ERP System Validation activities, CSV, SDLC, GAMP5
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