Quality Operations Director

1 week ago


Navan, Meath, Ireland Claran Consultants Ltd Full time

**Job Overview:**

Our client, Claran Consultants Ltd, is seeking a highly experienced Quality Assurance Operations professional to lead their quality assurance activities at their BioNX, Research & Development Division facility.

The successful candidate will be responsible for ensuring the site has a strong operational compliance focus aligned with cGMP regulations.

Key Responsibilities:

  • Maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations.
  • Providing quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.
  • Leading, facilitating and participating daily on cross-functional teams to collaboratively address compliance issues and achieve project milestones.
  • Participating in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
  • Providing QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.

This is an excellent opportunity for a seasoned quality professional to take on a leadership role and contribute to the success of the organization.



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