Quality Assurance Specialist

  • Location

    Hertfordshire, England

  • Sector:

    Healthcare

  • Job type:

    Contract

  • Salary:

    £20.00 - £25.90 per hour

  • Contact:

    Experis UK

  • Contact email:

    Paul.White@experis.co.uk

  • Job ref:

    PW/381_1590660681

  • Published:

    about 1 month ago

  • Duration:

    11 months +

  • Expiry date:

    2020-06-03

  • Start date:

    ASAP

  • Client:

    #

OVERVIEW:

Our client's Quality Assurance group ensures every single material inside their products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers they create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Assurance Specialist is a member of a team involved in supporting the Quality Assurance activities within Global Development Quality (GDQ), a department within the Company's Research and Development Organisation. GDQ is responsible for Quality Oversight of R&D manufacturing and testing activities and supporting release of Investigational Medicinal products for the Company's entire clinical trial portfolio worldwide.

KEY ACCOUNTABILITIES:

The Specialist is involved in supporting the GMP Quality Assurance activities at the UK site:

  • Completes audits to ensure compliance to SOPs, GMPs and applicable regulations.
  • Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
  • Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
  • Support product recalls and stock recoveries as appropriate.
  • Identify compliance gaps and make recommendations for continuous improvement.
  • Creates and maintains assigned SOPs.
  • Perform and review complaints and deviation investigations, change controls and CAPA's.
  • Assists in the induction process for new starters and training of other staff.
  • Generally, follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.
  • Compiles data for reports and presentations, provides data interpretation draws conclusions.
  • Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
  • Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
  • Represents department on cross functional teams.
  • Additional activities as assigned by the manager/supervisor

SKILLS/EXPERIENCE REQUIRED:

  • Bachelor's degree (or higher) in an Engineering or Science discipline.
  • At least one-year experience in the Pharmaceutical\Biotechnology industry, with a working knowledge of GMP.
  • Demonstrated ability to work independently and to drive the completion of tasks.
  • Team player, learning from and helping others overcome obstacles.
  • Effective communication, negotiation, problem-solving, and interpersonal skills are necessary to perform job responsibilities.

Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Experis within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.