IT Validation Manager

Job Type:
Job Sector:
£70 to £90 per hour
Salary Description:
Highly competitive rate
Quanta Consultancy Services Ltd
Job Ref:

Would you like your next, exciting role to be in the Netherlands, working as an IT Validation Manager? If yes, then this could be the role for you!

The contract is for an initial 18 months with the possibility of extension. You must speak English and Dutch would be a bonus. You would be responsible for providing support to Global QA in monitoring GMP compliance in the following areas:

- Computer system Validation
- Data Integrity
- Monitoring of GxP vendors of IT services

Job Content:
a)      Key Areas of Accountability / Responsibility

- To coordinate the validation of GMP relevant computer systems, in line with internal and external, global and local guidelines and regulations. 
- Ensure that adequate standards are established, maintained, communicated and effectively implemented for all systems and associated computer infrastructure. 
- Ensure that the change management process for evaluating new or revised software is implemented and that the appropriate validation activities are identified and carried out. 
- Participate as the quality representative on steering committees for all CSV and core business process projects to ensure that the necessary validation activities are identified and carried out. 
- Collaborate with programmers and developers on GxP relevant application bugs and enhancements. 
-  Perform benchmarking; record and document results and compare to expected results.
- Create validation templates and protocols (URS, FS, RA, VP, IQ, OQ, PQ, TM, VR) and executed validation test scripts per GAMP and V-model methodology.
- Supplier and GxP data integrity Assessments.

b.      Projects or Special Assignments

- Advising and supporting role in projects (validation approach, protocols, reports, test approach)

 Knowledge and educational level

- Thorough understanding of industry standards and best practices for computer system validation such as GAMP and ASTM E2500. 
- Strong knowledge of regulatory requirements (21 CFR Part 211, Part 11 and EU Annex 11) and basic validation practices (IQ/OQ/PQ).

Required level of experiences

- At least 3 years’ experience in Computer System Validation, Data Integrity, and auditing of suppliers of GMP relevant IT services.

For further information regarding the above, please get in contact with Kasim Zargar via the links below.

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Contact Details:
Quanta Consultancy Services Ltd
Tel: (0) 1442 861 735
Contact: Kasim Zargar

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