Computer Systems Validation Contractor

Location
Cambridgeshire
Salary
£400 to £500 per day
Posted
05 Oct 2018
Closes
02 Nov 2018
Ref
J563015
Contact
Georgia St John-Smith
Contract Type
Contract
Hours
Full Time
We are currently looking for a Computer Systems Validation (CSV) Contractor to join a leading Pharmaceutical company based in the Cambridgeshire area.

As the CSV Contractor you will be responsible for generation, review and approval of IT Qualification and Validation documentation to enable conformance with associated Health Authority Regulations (HAR), including GxP, US FDA 21 CFR's and SOX).

KEY DUTIES AND RESPONSIBILITIES:

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

1. As the Computer Systems Validation contractor, you will coordinate and support qualification and validation activities to enable the delivery of global IS Compliance projects, software rollouts and systems rollouts.

2. Your role as the CSV contractor will also involve implementing process improvements and working as apart of the Compliance team to provide oversight of HAR compliance requirements.

3. You will bring a variety of Computer Systems Validation experience to the compliance team in order to identify new opportunities for process improvements and operational effectiveness to ensure standards of Quality and Compliance are maintained.

4. As the CSV contractor, you will maintain effective dialogue with various IS process owners, management, and stakeholders in order to provide recommendations for RCA, implementation of remediation plans, CAPAs and mitigating controls.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the CSV Contractor we are looking to identify the following on your profile and past history:

1. Relevant degree in a Scientific or IT discipline alongside proven CSV experience in the Pharmaceutical industry.

2. Proven industry experience with supporting IT Compliance teams with Sarbanes Oxley (SOX) and HAR related audits.

3. A working knowledge and practical experience with taking a Risk Based Approach through knowledge of pharmaceutical industry regulations and guidance (GAMP5, Annex 11, FDA 21 CFR).

Key Words: CSV / Computer Systems Validation / Compliance / IS Compliance / IT Compliance / GxP / GMP / Systems Validation / Software Validation / SOX / HAR / Audit

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We 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 recruitment processionals and scientists. We look forward to helping you with your next career moves.

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