Quality Systems Associate

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United Kingdom
Hertfordshire, England
Posting date: 09 Oct 2019
QA.AC.25708_1570638753
This vacancy has now expired

A leading pharmaceutical client is searching for a Quality Systems Associate to join their team in the UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

Job Responsibilities:

  • Provide administrator level support for EML Quality Operations and QC Laboratory electronic systems.
  • Provide ongoing operation, maintenance, and implementation of improvements to electronic systems to support EMLs needs.
  • Coordinate with external system providers for helpdesk support.
  • Coordinate system updates and upgrades with the system providers, ensuring systems are maintained in a qualified state.
  • Coordinate with IT Team ensuring all systems are maintained in line with company policies.
  • Ensure procedures are in place for backup of data on electronic systems.
  • Generate qualification documentation in line with EML procedures.
  • Document and record all activities related to user errors in line with EML procedures.
  • Provide support to Quality Systems processes, SOPs, and Training management.
  • Provide day to day support to other members of the Quality Systems team, as appropriate.
  • Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working.
  • Perform any appropriate duties at the request of the Senior Manager Regional Quality Systems.

Skills and Requirements:

  • Basic knowledge of Quality Systems, GMP and basic understanding of manufacture and packaging of pharmaceutical products.
  • Good technical and scientific judgement.
  • Working knowledge of electronic systems and CSV requirements.
  • Understanding of GMP Guidelines and Regulations.
  • Understanding of Computer Systems Validation (CSV) and GAMP.
  • Experience of ICT and business system lifecycle management preferably in a pharmaceutical manufacturing or other regulated environment.
  • Documentation and testing experience of ICT systems.
  • Broad range of knowledge in systems/applications relevant to pharmaceutical manufacturing.
  • A working knowledge and practical experience with writing SOPs and validation documentation (protocols/reports) as well as a knowledge of modern IT infrastructure.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alexander Coltman at +44 2038542472 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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#Compliance/Quality

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