Quality Systems Manager

Posted 6 February by Marketplace Group

Pharmaceutical Manufacturer requires a Quality Systems Manager to be responsible for The Quality Systems Management, Validation and Technical Documentation to ensure that all products are produced in accordance with the requirementsoftheappropriateProductLicencesinfullaccordancewiththeguidelines forGMPaslaiddownintheEUdirectives.ToactastheMAHdeputyQPPV.

JOB DUTIES:

  • To act as the MAH Deputy QPPV. To liaise with the Qualified Person for PharmacovigilanceonanycomplaintsandSPCupdatesrelatingtoadverse effectsandsafetyinformation
  • ToevolvetheQualitySystemsinlinewiththeEUGMPdirectives.Totrain,manage andmonitortheQualitySystems.
  • Toreview,adviseandapprovechangecontrolsanddeviations.
  • ToreviewandapproveSOP’s,ManufacturingandPackagingmastersandother technicaldocuments.
  • Toreviewandevaluatecompletedmanufacturingandpackagingdocumentsto ensure that each batch has been produced, tested and packed in accordance withthedirectivesandthemarketingauthorisationasrequired.
  • Tocontrol,organiseandcarryout(asrequired)APIandSupplierAudits.
  • TocontrolandorganiseSupplierApproval
  • Tocontrol,adviseandcarryout(asrequired)allvalidationactivities.
  • ToinvestigateinaccordancewithwrittenproceduresallADR’s,complaints relatingtothequalityoftheproductsandifsubstantiatedtoinitiateactionto preventrecurrence.
  • ToliaisewiththeQualityAssuranceManageronallaspectsofProductChange anddeviationsfromspecificationandthevalidationrequiredbeforechanges can beimplemented.
  • ToliaisewithQualityAssuranceManagertoensurethatchangestothedirectives areincorporatedintocompanypolicyandsystems.
  • ToparticipateinthepreparationandhostingofMHRAandcustomerinspections.
  • Tocontrol,instigateandparticipatein"self-inspections".
  • TocreateandcarryoutGMPtraining
  • Provideback-upfortheQualityAssurancemanager

Reference: 34411428

Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Report this job