Reference Number: JO-2108-475098
GMP Quality Assurance Associate
Rate: Negotiable
Job Type: Contract
Location: Hatfield

We are seeking someone on a 12 month FTC working with a manufacturer of Pharmaceuticals based in Hertfordshire.

1.Main duties/responsibilities:

  • To review batch records, associated documents and to approve intermediate product.
  • To support approval of updated master batch records, QC test methods, label text, Supply Strategy Study Documentation and any associated documents.
  • To write under supervision, SOPs associated with DQA activities.
  • To participate in internal and external audit process and audit schedules.
  • To support the preparation and hosting of competent authority inspections.
  • To support the processes associated with the development and review of Quality Agreements.
  • To raise and support the investigation of deviations and associated CAPAs.
  • To raise and support the investigation of customer complaints.
  • To review qualification/validation protocols and reports.
  • To support testing the effectiveness of DQAs EU product recall procedures on an annual basis.
  • To support the implementation of change control activities.
  • To generate and maintain Product Specification Files.
  • To assist with Eisai supported Investigator Initiated Studies.
  • To represent the DQA at clinical study team meetings cross functional meetings.
  • To arrange identification testing for imported Investigational Medicinal Products.
  • To request batch certification and temperature monitoring data.
  • To provide support to other members of the DQA team and EPCS, as appropriate.
  • Identify and implement Continuous Improvement opportunities that result in cost savings and more efficient and compliant ways of working.
  • To perform any other appropriate duties at the request of the Director, QA GMP, and to deputise for them, when appropriate.
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