Due to changes in GDPR and increased usability with the website, any candidates registered before 03/05/19 will need to re-register
Hyper Recruitment Solutions
Back to results

Computer Systems QA Specialist

CambridgeshirePermanent
£30,000 - £35,000 per annum
Job Reference: J5631932
Updated On: 24/07/2019
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, IS&T

Skills: IS&T - Change Management, Quality Assurance - Compliance, Quality Assurance - Validation, Quality Assurance - ISO9001, Quality Assurance - CSV, Quality Assurance - Documentation, IS&T - Data Integrity, IS&T - Testing

Job Information

Role Overview

We are currently looking for a Computer Systems QA Specialist to join a leading pharmaceutical company based in the Cambridgeshire area. As the Computer Systems QA Specialist you will be responsible ensuring that IT systems are maintained and validated to various pharmaceutical regulations

Key Duties and Responsibilities

Your duties as the Computer Systems QA Specialist will be varied however the key duties and responsibilities are as follows:

1. You will be supporting the IT and Quality teams in ensuring that IT systems are maintained and validated to various regulations such as GxP, GAMP, ISO27001, FDA 21 CFR Part 11

2. You will be involved reasonable tasks that are requested to help ensure that the highest standards of quality are achieved and maintained within the company’s validated systems.

3. Review and approve relevant Change Control Requests managed via IT Change Management System and manage the provision of relevant documentation to support the implementation and validation of changes as appropriate.

4. Perform periodic evaluations of computerised systems to confirm they remain in a validated state and are compliant with GxP.

Role Requirements

To be successful in your application to this exciting opportunity as the Computer Systems QA Specialist we are looking to identify the following on your profile and past history:

1. You will need experience in the Rules Governing Medicinal Products in the European Union; Vol. 4, Good Manufacturing Practice; Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems


2. You will have to demonstrate strong IT skills including CSV

3. Be a team player who has worked in a highly regulated pharmaceutical environment


Key Words: IT Systems, CSV, Validation, Quality, ISO, IT Change, GxP, GAMP
David Powell
Your Recruitment ConsultantDavid Powelldavid.powell@hyperec.com
DisclaimerHyper 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.