Science & Pharmaceutical JobsQuality Systems Analyst (Maternity Cover)

  • GY50284
  • Temporary/Contract
  • Galway

Collins McNicholas

Quality System Analyst required for a Maternity Cover contract – pharmaceutical 

Role Purpose

Operating within the Quality team to ensure commercial products are manufactured and distributed in accordance with all regulatory and corporate requirements.

This role will require a systematic and thorough approach to robust Quality System implementation, and cooperation with all functional teams in order to support the maintenance of an effective Quality System.

Key Duties

  • Coordination and Management of Quality System Records relating to Document Control, Training, Deviations, Non-Conforming Material Reports (NCMRs), Corrective & Preventive Action (CAPA), Internal Audit, etc.
  • Management of Quality System Metrics to support Corporate QHS initiatives.
  • Participate and lead, where relevant, the on-going development of both Corporate and site-level Quality Systems.
  • Lead or participate in Internal Audits to assess compliance to the Regulatory and Quality Management System procedure requirements.
  • Provide timely issuance of Internal Audit reports and/ or CAPAs.
  • Provide timely follow-up on Audit responses and Corrective Actions, and track the completion of activities from scheduling through to audit closure.
  • Devise or revise Standard Operating Procedures relating to various quality system elements.
  • Provide Quality System support to Manufacturing, Engineering, Supply Chain, Human Resources and Warehouse.
  • Provide support for Root Cause Investigations, relating to NCMR and CAPA proposals and initiatives.
  • Be the Subject Matter Expert for the Quality department on software integrations that affect the Quality System, such as SAP, Trackwise, etc.

Key Requirements needed

  • Bachelor’s Degree in Science, Engineering (mechanical, industrial, chemical, electrical) or equivalent discipline is preferred.
  • Minimum 3 years of Medical Device Quality experience in an ISO/ FDA regulated manufacturing environment. Document Control experience is essential. 
  • 5 or more years of experience preferred.
  • Competent using office software including MS Word, Excel, Internet Explorer, Powerpoint and Outlook. Experience working with Compliance Wire is preferred.
  • Strong knowledge and understanding of FDA regulations (21CFR 820), ISO13485 and other ISO standards related to medical device manufacturing as required by the position.

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