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QA Specialist

Hertfordshire   •  Contract/Temporary, Full time

CK Group are recruiting for a QA Specialist to join a company in the healthcare industry at their site based in Stevenage on a contract basis for 6 months.

Hourly rate up to £27.44 DOE

QA Specialist Role:

  • Ensure the laboratory complies with all QMS and relevant regulatory standards in relation to laboratory data generation and approval, maintain relevant GxP training compliance requirements, support delivery of training courses and relevant learning material and assure compliance with method SOPs.
  • Initiate and coordinate deviation and change control notifications in the SAP system, complete CAPAs and change control tasks and participate in root cause analysis for deviations, customer and service complaints.
  • Take ownership of quality systems (e.g. deviations, change controls), Control Printing, Reconciliation Process and site Curricula Review Process; including provision of metrics and report program trends on a periodic basis and review and initial approval of LI notifications in SAP system.
  • Manage the archiving for all documentation both on and off-site.
  • Assist in the preparation for and participation in regulatory agency inspections, corporate, customer and monitoring audits including audit readiness assessments as required.

Your Background:

  • Bachelor of Science in Science, Engineering or other technical discipline.
  • Significant experience working in a GMP regulated environment in a role directly related or supporting Quality or Manufacturing.
  • You will have an ability to review of complex GMP records and data and have a thorough understanding of GMP regulations
  • Laboratory experience would be preferred.

Our client is a global healthcare company, taking on some of the world\'s biggest healthcare challenges.

This QA Specialist role will be based at our clients site in Stevenage, Hertfordshire.

For more information, please contact the team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 51844.

Please note that the successful applicant will be required to engage via an FCSA-accredited and CK-approved umbrella company and the rate of pay indicated is an umbrella rate.

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Julie Marshall
  • Phone: 01438 723 500
  • Reference: 51844
  • Posted: 6th October 2021
  • Expires: 3rd November 2021

CK Group

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