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View Cache (Job ID 13850189)
Employer ICDS Recruitment
Job Title Quality Compliance Officer

Quality Compliance Officer - County Waterford

In this role you will support the Quality Compliance Team, with activities associated with the regulatory compliance of products in Worldwide markets including US, EU and Japan.


  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Ensure high quality output – Vigilantly watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects.
  • Initiate action to correct quality problem and notify others of quality issues as appropriate. If a procedure does not exist, devise one, (through the appropriate channels); if a process needs amending, do so through the appropriate channels.
  • To prepare annual Product Quality Reports for all commercial product as per defined schedule and cGMP’s.
  • Review all annual Product Quality Reports that are received from third party contract facilities as per cGMPs.
  • Initiate and progress any deviations identified as per quality procedures.
  • Completion of change controls and reviews to facilitate QP release in a timely manner.
  • Participation in outside Inspections (Customer audits / Regulatory inspections).
  • Strategic planning of regulatory compliance activities to support QP release of products; including initiation and/or progression of all regulatory change controls.
  • To ensure regulatory compliance of all customers' registered details with internal documentation, and where differences occur liaise with Regulatory affairs and applicable departments to correct; through review of regulatory customer information sheets.
  • To maintain the Customer Compliance index and ensure that all non-compliances that will not be corrected are recorded here.
  • To ensure that internal procedures meet the regulatory requirements to maintain licences.
  • To provide due diligence support for potential activities that may have a regulatory impact.
  • To maintain detailed records of all compliance reviews in an orderly and compressive manner.
  • Assist in the renewal or creation of Manufacturing Licences and associated fees.
  • Prepare QP declarations to support the Regulatory Affairs department.
  • Assist with the control of contract facilities from a regulatory compliance perspective.
  • Review all complaints to assess if there is a PV implication and report to relevant party within the pre-defined timeline.
  • Assist with the monitoring of PV metrics of contract facilities as required.
  • Ensure that PV master plans are reviewed, adequate and in place to support activities in the areas of Bio-equivalence and Clinical safety and efficacy study management.
  • Ensure PV agreements are in place as required by regulatory agencies.
  • Review and make effective customer specific PV agreements; ensure compliance with these agreements.
  • Liaison with customers regarding PV reconciliation.


  • Minimum B.Sc. required, preferably in Science, Pharmacy or Pharmacology.
  • Previous pharmaceutical experience required; quality and/or regulatory affairs experience desirable.
  • Lead Auditor qualification an advantage
  • Familiarity with cGMP in pharmaceutical manufacturing.
  • Familiarity with concepts of Regulatory Approval process for generic pharmaceutical products.

This job originally appeared on
Location Waterford
Date Added 68 days ago
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