Job description

I'm delighted to be recruiting for a Quality Systems and Compliance Manager role with one of our Waterford based clients. In this role, you will manage and ensure the compliance of the company’s Quality Systems and you will support the Head of Quality with activities associated with the regulatory compliance activities of the company’s products in Worldwide markets including US, EU and Japan. This is a full time permanent role and comes with an excellent salary package.

• Quality System includes: Documentation, Training, CSV Governance, Supplier Quality
  Management, QUMAS eDMS, TrackWise eQMS and LMS
• Data bases for the quality system, metrics and quality trending reports, compilation and
  distribution of departmental monthly, quarterly and annual metrics
• All documentation relating to the company, cGxP, regulatory regulations and guidelines.
  Check own work/documentation and that of others for accuracy. Site documentation archival
  and retrieval processes
• Supporting the department budgeting process
• Support the evaluation of quality deficiencies, incidents and possible complaints and the
  follow-up activities in the GMP departments. Escalation of critical Quality issues where
  required
• Ensure that all customer requests are dealt with within a reasonable timeframe & provide
  assistance to customer with regard to license renewals.
• Ensure on time approval of annual Product Quality Reports for all commercial product as per defined schedule and cGMP’s, review reports that are received from third party contract facilities
• Completion of change controls and reviews to facilitate QP release in a timely manner
• Self-inspection program as per the defined schedule. Preparation & 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 regulatory change controls
• Ensure regulatory compliance of customers registered details with internal documentation

If this role is of interest, please apply below or email julieannfitzpatrick@sigmar.ie

Interviews are taking place ASAP