CSV Engineer Consultant / Contractor

3 days left

Location
Peterborough
Salary
£40 to £50 per hour
Posted
05 Apr 2017
Closes
03 May 2017
Ref
J3759
Contact
Georgia St John-Smith
Contract Type
Contract
Hours
Full Time
We are currently looking for a CSV Consultant to join a leading company based in the East of England.

As the CSV Consultant you will be the Quality Lead for the implementation of a Unique Device Identification (UDI) Label Management System for a Medical Devices Company.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the CSV Consultant will be varied however the key duties and responsibilities are as follows:

1. Act as the CSV Quality Lead on the Implementation of a UDI Label Management System. This will include implementing new Technical Infrastructure as well as asligning the Labelling System with existing Software Platforms.

2. Validation of applications against GXP guidelines for GXP Qualification and Compliance.

3. Implement new designs, standards and procedures to align the IT Infrastructure and applications as per Regulatory Standards in the Medical Devices and Pharmaceutical Industry.

4. Ensure all systems are compliant against qualified technical specifications and met throughout the life cycle of the Systems. Developing and applying processes to assess the Data Integrity requirements and impacts, to integrate this into the established CSV processes.

ROLE REQUIREMENTS:

To 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 / Qualification in a Technical or Scientific Discipline

2. Proven industry experience in the Pharmaceutical or Medical Devices industry is essential.

3. A working knowledge and practical experience with CSV Compliance, Computer Systems and Label Management Systems.

Key Words: CSV / Computer Systems Validation / Validation / IT / Infrastructure / Technical / Labelling / Label / UDI / Unique Device Identification / Medical Devices / Implement / GAMP5 / Trackwise / Prisym / Prism / Systems Validation / Pharmaceutical / Quality Assurance / Quality / Lead / Regulatory / Compliance / Data Integrity

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.

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