Research Quality Association

Dstl

GXP Quality Assurance Specialist

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Description

At Dstl, we’re responsible for designing, developing and applying the very latest in science and technology for the benefit of UK defence and security, across government. In our work, we partner with other brilliant people – collaborating with everyone from small companies and world-class universities, to large defence organisations and other nations. Together, we explore deep and widespread research to develop cutting-edge technologies.

We’re now looking for GXP Specialists to join our Quality Assurance Unit. As part of world-leading research and development team, you’ll apply your expert GXP knowledge to improve the progress of pharmaceutical product development. To enhance our products, you’ll plan, prepare and carry out audit reports that push us to do our best work. You’ll also interpret, analyse and share GXP and scientific findings to colleagues outside your team, so it’s fundamental you can express your ideas clearly. Your conclusions will be a key factor in decision making both within and outside of Dstl. So it’s essential you have experience in a Quality Assurance environment as a Quality Assurance professional and significant experience within a GMP environment would be a distinct advantage but not essential.

With that expertise, you’ll deliver and review GMP, GLP and GCP study reports in a timely manner. So whether you’re working on products related to biologicals, small molecules or vaccines, you’re helping us be the best we can be. You also know what it’s like to be a QP, and have working knowledge of good manufacturing practice and laboratory environments. It’s a fast-paced, challenging role, but you’re the sort of person who enjoys overcoming challenges to reach a common goal. It’s this shared motivation to help protect the UK that drives us to push pharmaceuticals further.

The Quality Assurance GXP Specialist will report directly to the Team Leader for the QAU. The primary responsibility will be to provide expert advice and audit GXP systems. The role will compliment the existing Dstl senior QA representative. The main responsibilities that fall within your remit will be to:

  • Plan, prepare, carry out and write GXP systems Audit Reports for both Dstl and external contracted facilities.
  • Provide statistics, data and trend analysis reports
  • Provide expert review of a wide range of GMP documentation (eg SOPs, Batch manufacturing records, validation protocols and reports etc)
  • Manage corrective and preventive action reports and QMS activities
  • Review GLP/GCP/GMP Study Reports.
  • Provide support to GCP activities as required.
Requirements

We are looking for someone who has;

  • Extensive QA experience, particularly in the area of GMP and pharmaceutical manufacture and testing
  • Good interpersonal skills, including the ability to form strong working relationships with the existing Dstl medical, veterinary and scientific staff and military and non-military partners including CROs and CMOs.
  • A team player with a track record of working in successful teams
  • Drive and the aptitude to take responsibility for specific areas of work
  • The ability to understand how their work would fit into the bigger picture of regulated work at dstl.
  • A desire to contribute interesting research in support of serving military personnel
  • A desire to further learn and develop their careers


Security Clearance: This is a RESERVED position and requires full UK Security Clearance. Candidates should have resided in the UK for the past 5 years. Dual Nationals cannot be considered for these roles.

Job Information
  • Location:
    Salisbury, South West England, SP4 9JQ, United Kingdom
  • Job ID:
    48591712
  • Posted:
    May 23, 2019
  • Position Title:
    GXP Quality Assurance Specialist
  • Company Name:
    Dstl
  • Industry:
    Pharmaceutical
  • Job Function:
    Quality Assurance
  • Entry Level:
    No
  • Job Type:
    Full-Time
  • Job Duration:
    Indefinite
  • Salary:
    32,000.00 - 53,500.00 Pounds Sterling (Yearly Salary)
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