Company : Austin Fraser
Job Location : England, gb
Posted on : 2021-04-13
Job Description :
IT Systems Solutions SpecialistMy pharmaceutical client is searching for an IT Systems Solutions Specialist to join their Quality department.
The right candidate will be responsible for the management, coordination and support of activities relating to the maintenance, development, troubleshooting, auditing and validation of GMP-relevant IT application systems and IT infrastructure components, such as Trackwise, Empower, Tiamo 2.
5 and WinLab UV.
Key Responsibilities 1.
Create, maintain and modify user accounts and passwords on GMP relevant application systems and IT infrastructure components.
Create and maintain methods in Laboratory Computer systems.
Validate new software and systems.
Perform troubleshooting and monitor server space to prevent downtime andexcepted failures.
Launch, lead or support project activities linked to the implementation of new or changes to existing Quality IT systems and softwares.
Run monthly QC project meetings with IT, Validation, QCCCTS and QC to update status of ongoing projects.
Provide technical guidance/advice and training for other team members on the use of systems.
Communicate with Development in the initiation of new items and products in the Quality Computer Systems4.
Complete Data Integrity assessments of all QC systems and data generated by Quality Control.
Knowledge and ExperienceExcellent knowledge in the field of quality assurance of Computerised systems including FDA (CFR Part-11) compliance requirements.
Excellent knowledge of Qualification of IT infrastructure and Validation of Computerised Systems within a GMP regulated environment.
Thorough knowledge of GMP requirements.
Strong written and verbal communication skills.
Project manager skills.
Experience of Pharmaceutical Production and associated equipment systems.
Experience using SAP with quality function.
Training individuals at all levels in Empower, Trackwise, SAP and other associated systems.
If this sounds like something you would be interested in, please apply below as soon as possible.
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants