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Quality Specialist - CSV - SRG

Posted: 5 July 2018

Closing: 13 August 2018


Job Title: Quality Specialist - CSV
Vacancy type: Permanent
Area: North Yorkshire
Salary: Competitive

SRG are working with a leading drug service provider who are looking for a QA Specialist in CSV to join their global quality team. Reporting to the Director of R&D, this role will involve the management of QA functions of the computer systems validation.

The role:
• Representing QA on project teams aimed at validating new or upgraded computer system s and instrumentation
• Reviewing and approving key computer system validation deliverables
• Defining and managing inspection program(s) that are operated to assure the compliance of our computerized systems, instrumentation, and electronic records.
• Leads a programme of training relating to compliant Computer System Lifecycle Management and Data Integrity Assurance

Requirements:
The ideal candidate should be educated to degree level or equivalent and should have a demonstrable equivalent experience as follows:

• Experience working in the Pharmaceutical or related Industry, preferably in a QA/compliance role and fully familiar with Good Practice Regulations (GLP, cGMPs, GCP)
• Working knowledge of regulatory agency guidelines relating to Computerized System Compliance/Data Integrity and Industry Standards, e.g. GAMP5.

This is an exciting opportunity for a QA Specialist to join global drug service provide and to be part of their global quality team.

SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.

As scientists ourselves, our specialist sector knowledge and our passion are second to none. It’s this combination that makes us different. We’re committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.

If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV to Jude Madathilethu at jude.madathilethu@srg.co.uk. For more information regarding this position or any others, please call Jude on 0161 868 2212.

If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.

Keywords:
Quality Assurance, QA, Quality Specialist. Computer system validation, CSV, computerised system, Biopharmaceutical, Bio-Pharma, Pharma, Pharmaceutical, CAPAs, Deviations, Change Control, NCR, root cause analysis, risk assessment, QMS, Quality Management System, QBD, quality by design