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Quality Assurance Specialist

2 months ago

Glasgow, Glasgow City, United Kingdom CDM Recruitment Ltd - Life Sciences Full time £30,000 - £35,000
Job Description

We are seeking an experienced Quality Assurance Specialist to join our client's team at CDM Recruitment Ltd - Life Sciences. The successful candidate will report directly to the QA Manager and be responsible for ensuring Quality Assurance activities are compliant with current Good Manufacturing Practice (GMP) and company expectations.

Key Responsibilities:

  • Provide QA input to activities including review and approval of risk assessments, specifications, Standard Operating Procedures, and other documentation types as required.
  • Review and approve batch manufacturing data sets in accordance with procedures for GMP, prior to passing to Qualified Person for batch confirmation / certification.
  • Audit and/or Review GMP validation reports, protocols, reports to ensure that they are internally consistent, accurate and completely reflect the raw data set and meets the current Good Manufacturing Practice standards and regulations.
  • Be involved in the preparation for regulatory body audits.
  • Perform data integrity audits/checks for GMP, GCP and non-GxP data as necessary to assure data integrity.

Requirements:

  • Degree/HNC in science discipline or at least 4 years working experience within a Quality Assurance role in a GMP regulated company, preferably in the pharmaceutical, ATMP industry.
  • Knowledge of applicable GMP regulatory requirements and understanding of PQS requirements.