Job Reference: J5634100
Updated On: 25/03/2021
Status: Now Interviewing
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Role OverviewWe are currently looking for a IT Quality Systems Specialist to join a leading Pharmaceutical Contract Development and Manufacturing organisation based in the Kent area. As the IT Quality Systems Specialist you will be responsible for maintenance, development, troubleshooting, auditing and validation of GMP-relevant IT application systems and IT infrastructure components, such as Trackwise, Empower and Tiamo 2.5.
Key Duties and Responsibilities1. Create, maintain and modify user accounts and passwords on GMP relevant application systems and IT infrastructure components.
2. Create and maintain methods in Laboratory Computer systems.
3. Launch, lead or support project activities linked to the implementation of new or changes to existing Quality IT systems and software's.
4. Provide technical guidance/advice and training for other team members on the use of systems.
Role Requirements1. Excellent knowledge in the field of quality assurance of Computerised Systems including FDA (CFR Part-11) compliance requirements.
2. Excellent knowledge of Qualification of IT infrastructure and Validation of Computerised Systems within a GMP regulated environment.
3. Strong computer skills and knowledge of pharmaceutical quality systems such as, Empower and Trackwise.
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