Quality Compliance Specialist

138060
  • 50000 EUR - 53000 EUR
  • Dublin, United Kingdom
  • Permanent

Within this role, the Compliance Quality Specialist is tasked with upholding ongoing compliance with the Quality Management System. The responsibilities encompass overseeing the Document Management system, coordinating document change requests, providing training and analytical support for GMP systems (MasterControl, SAP, etc.), and actively contributing to various Quality projects. The position extends to onboarding new hires, conducting global data analysis and reporting on Quality System Metrics, and managing diverse compliance-related responsibilities.

 

Key Responsibilities:

  • Fulfill the role of Sub Administrator for the site Quality Event Management System, ensuring accountability and traceability of Quality Records.
  • Offer oversight on Quality document control, guiding documentation structures and formats for compliance with procedures, regulations, and standards.
  • Collaborate with the Global Systems Administrator for software updates and MasterControl System validation.
  • Manage on-site Systems Training, Document Management Training, and GMP Training.
  • Generate data for Management Review and oversee the generation and reporting of Site Metrics.
  • Manage an off-site Records Management Supplier.
  • Ensure compliance with GMP review requirements and customer specifications.
  • Collaborate cross-functionally for successful documentation release and act as a compliance representative on Quality Projects.
  • Participate in the Internal Audit Program and provide support for Third-Party Audits.
  • Track and analyze QMS compliance issues to drive continuous improvements.
  • Foster collaboration with other West sites to share best practices.
  • Adhere to the company’s Guiding Principles, Code of Conduct, and all Environmental, Health, and Safety requirements.

 

Requirements:

  • Demonstrate a thorough working knowledge of quality systems, such as ISO 13485, 21 CFR Part 820, and/or EU GMP.
  • Exhibit excellent communication and written skills.
  • Preferred experience in auditing to ISO 13485/21 CFR Part 820/EU GMP requirements.
  • Display the ability to thrive in a fast-paced environment, effectively prioritize tasks, and pay meticulous attention to detail.
  • Showcase strong collaboration and team-oriented skills.
  • Maintain a focus on customer requirements.
  • Uphold compliance with safety and quality policies.
  • Actively support and contribute to Lean Sigma programs.

 

Do not miss out on this opening – apply below or contact Ryan Tanner at Meet or email directly to ryan.tanner@peoplewithchemistry.com

Ryan Tanner Division Manager

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