QMS Specialist

  • Contract
  • Cork

Website TPM05454

Summary:
A QMS Specialist is required for a biotech company in West Cork. The successful candidate will be accountable for the Quality Systems within the site.

Responsibilities:

  • Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/ Change Management.
  • Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Ensure supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
  • Ensure the highest Quality, Compliance and Safety standards.
  • The Associate Specialist/ Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership.
  • The Associate Specialist/ Specialist is accountable for the smooth execution of all appropriate documentation associated within the Operations/QA.
  • Contribute to the High-Performance culture within the Operations/QA by providing a flexible, accurate service to enable the Operations/QA to achieve four key priorities.
  • Is an active member of the cross functional Operations/QA Team, providing support, guidance and expertise to ensure the success of the Operations/QA.
  • Will participate and comply with the Quality Management System (QMS) requirements, including ownership.
  • Provides to the site knowledge and experience in Quality Documentation Systems.
  • Responsible for the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of products.
  • Complete documentation audits.
  • Coaches and guides colleagues within the site.
  • Responds to non-standard requests from customer needs.
  • Ensures supply of high-quality product through the implementation and oversight of the Quality Documentation System for the site.

Qualifications & Experience:

  • Relevant degree.
  • 2 years’+ working experience.
  • Experience working in a GMP environment.
  • Experience in QMS.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.