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QA Administrator

Central Employment Agency (North East) Limited
Job LocationNewcastle Upon Tyne
EducationNot Mentioned
Salary22,000 - 24,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeTemporary , full-time 12 weeks

Job Description

Central Employment are looking to recruit two QA Administrators based in Newcastle, as we support a manufacture of bespoke medicines for global markets.Were looking for both temp-perm and also a MAT 12 month cover contract.Role Purpose:

  • Assist to QA Officer, QA Manager and QP
  • Keep track of All GMP documents / logs. (Change control, Deviation, CAPA, Training)
  • Check availability of QPs, keep records and allocating the work to QPs (batch release)
  • Ensure data logger information is available & complies for all batches.
  • Change control, OOS & Deviation documentation
  • PQR preparation, review & maintenance of documents.
  • Responding to Quality related market complaints, customer enquiries & documentation.
  • Issuance and review of BMR / BPR.
  • Issuance of COC (Certificate of Conformance)
  • Perform investigation related to deviations or market complaints.
  • Perform self-inspection.
  • Perform In-process checks.
  • Assist to validation and Qualification activities
  • Co-ordinate with commercial /Logistics for planning timely release of the batches.
  • Coordinate with FP (bulk) site to get the documents in time.
  • Coordinate with Warehouse/QC to send samples for testing site in time. Coordinate with QC to minimise the analytical times as per plan.
  • Ensure batch documentation is obtained & reviewed on timely basis & provide necessary feedback to QPs for batch release.
  • Ensure data logger information is available & complies for all batches:
  • Updating warehouse & Logistic on the release status and keep log and release related documents up to date and in retrievable manner.
  • Ensure that the batches going to release are in compliance with licence i.e. artwork of carton, leaflet & foil, Expiry date, pack type & storage conditions.
Essential:
  • Will have excellent organisational and administration skills, be a good team player, with good interpersonal, communication, motivational and organisational skills.
Desirable:
  • To have a considerable working knowledge of a manufacturing, technical environment.

Keyskills :
AnalyticalComplianceDataDocument Management

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