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Karen Shiel
Life Science

+353 1 5079256
[email protected]
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Details

Quality Compliance Lead


Reference:KS/ASPF-005370 Location: Donegal
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Auditor, Quality Specialist, Quality Systems Lead, Quality Systems Specialist

Our client is a global healthcare leader with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. They serve the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products.

This plant in Donegal manufactures blood glucose test strips and sensors for use in diabetes management.

They are currently seeking a Quality Compliance Lead who’s main responsibility shall be to lead Site Audit Readiness and be a member of the Quality Systems team in the Quality Department. Reports to the Quality Systems Manager.

Role/Responsibilities:

  • Manage site audit readiness activities across the site ensuring areas are audit ready at all times
  • Manage QR’s related to audit findings ensuring implementation of timely and effective corrective actions
  • Maintain and update the plant Risk Register
  • Represent our client to internal/external Auditors and Regulatory bodies on any matter relating to area of responsibility
  • Ensure area of responsibility and processes are audit ready at all times and all audits are supported from a resource and information request perspective
  • Act as External audit generalist as required
  • Lead and coordinate the audit backrooms during external audits.
  • Conduct and own Plant cGMP compliance process
  • Build and maintain effective cross functional relationships with all areas of the business.
  • Maintain an appropriate balance of quality, compliance, and business risk. Provide compliant yet practical solutions that minimise the impact of Quality issues
  • Identify and implement initiatives for continuous improvement of the Quality System
  • Ensure effective communication and leadership to management and other staff on compliance issues and site audit preparedness
  • Provide divisional level support and guidance as SME for area of responsibility
  • Ensure approaches to Quality and Compliance are consistently applied within the business and across the Division
  • When requested, accept any responsibilities, and perform any necessary tasks to support the business and other Quality activities
Skills:
  • Candidate must be self-motivated with good communication skills.
  • Work within a team environment
  • Involvement with ongoing Department and site wide projects.
  • Membership of Cross Functional Teams as part of continuous improvement opportunities.

Education/Experience:
  • Bachelor’s Degree: BSc/BEng scientific, engineering, or related discipline or an equivalent combination of education & work experience
  • 3 years’ experience in Quality Management Systems & prior experience of the manufacture of regulated products to ensure familiarity with GMP and/or ISO Quality System requirements.
For further details please contact: Karen Shiel on 087 7452487 or send CV to [email protected]