Quality Compliance Officer

ICDS Recruitment

Waterford

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. Responsibilities: 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. Requirements: 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 RecruitIreland.com.

2299 days ago