IT Quality System Support GXP
IT Quality System Support GXP
Posted on :
28-11-2024
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1 Vacancy
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Job Description
We are seeking highly IT Quality System Support to join our team as consultants for a leading global pharmaceutical company.
Main Tasks:
Review and compliance sign off for SLC activities related to IT infrastructure qualification and validation of application systems used in IT (e.g. change control risk assessment configuration and installation testing functional and requirement testing periodic review exception monitoring etc.) thus ensuring all deliverables meet regulatory requirements including computer systems validation electronic records data integrity and signature requirements
Advise/consult System Leads and teams in creation and execution of IT changes
Monitor adherence to Corporate IT Regulations
Requirements
- Fluent in written and spoken English
- Masters degree in computer science
- Solid experience with quality management systems (e.g. GAMP) and IT standards (e.g. ITIL)
- Indepth knowledge of the regulatory environment (e.g. GxP audits) and information technology
- Indepth knowledge of GxPrelevant IT processes and their support by computerized systems
- Excellent communication skills analytical thinking and the ability to work in a spirit of partnership
- Ability to build consensus and influence decisions
Employment Type
Full Time
Key Skills
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