HRS Hyper Recruitment Solutions: IT Quality Specialist - 6 month FTC

We are currently looking for an experienced Quality Assurance Specialist to join the quality management systems team for a global biotechnology company based in the Berkshire area. This position is on the basis of a 6 month fixed term contract (employed by the business and paid a salary) to act as maternity cover.

ROLE OVERVIEW:

The role will assist with the validation and administration of the global GxP critical computerized systems, and manage the training profiles and modules of our client's IT Quality team. The role will require good communication skills and the ability to build and maintain relationships with the team, the Global Quality department, IT and the end users of the global GxP critical computerized systems.

KEY DUTIES AND RESPONSIBILITIES:

The successful IT Quality Specialist will take responsibility for a broad range of experiences including (but not limited to) the following:

1. To manage the global electronic quality management system in a GMP relevant environment and coordinate development, projects, and changes to the system. IN doing so to adhere to and participate in testing of Corporate IT Computer Systems.

2. Adherence to and participation in Change Management for Corporate IT Computer Systems, evaluation of change criticality during the impact assessment of EICRs, closure of EICRs pending QA Closure and participating in the Risk Assessment.

3. Creating training modules for our client's IT Quality Team with regards to IT Computer Systems.

ROLE REQUIREMENTS:

To be considered as the IT Quality Specialist we are looking to review profiles from those who can demonstrate the following in their previous experience. As this role is for a 6 month basis we require somebody who can hit the ground running and therefore limited to no training will be provided:

1. Degree (or equivalent) in a relevant life sciences and / or computer science discipline with proven experience working in IT systems validation and its application to GMP processes e.g. manufacturing process, laboratory and business systems.

2. Proven experience in Quality Management, Quality Studies (i.e ISO accreditation or equivalent QMS), auditing computerized systems and/or GMP operations with a basic knowledge with LIMS, DMS, TrackWise and other corporate systems.

3. Those with recent experience at a managerial level for Quality with responsibility for approving validation plans, protocols and reports relating to GMP processes will take priority.

Key Words: CSV, IT Systems Validation, Quality Specialist, Quality Assurance, GMP Quality, Trackwise QMS, Quality Auditing

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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