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CMC QA EU Validation Lead, Dublin



Dublin, Ireland 

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Job Description:

The Opportunity

Team Horizon has a vacancy for a CMC QA EU Validation Coordinator to coordinate the development and maintenance of the company’s validation program in compliance with all applicable regulatory and the company's requirements to ensure flawless NPI PPQ execution across the network operations manufacturing sites. In this role, you will lead communication planning, preparation and actions to ensure improvements are harmonized and shared across the manufacturing network and the quality system documents and IT systems are aligned accordingly.

The Role

  • Develop and implement global strategic initiatives to ensure New Product Introduction PPQ’s are executed RFT, including:
  • Co-ordination and direction of the qualification of site equipment, facilities, utilities, processes, cleaning and software in compliance with company policies, FDA, European cGMP and GAMP standards to ensure they meet the requirements for NPI’s.
  • Collaborate with partners including Global and Site Operations and QA, S&T and R&D to drive broader network efficiency
  • Review / Approval of Project Validation Plans associated with New Product Introductions.
  • Review / Approval of validation protocols and final reports associated with New Product Introductions to cGMP standard
  • Review / Approval and Oversight of validation change control processes across all sites with New Product Introductions
  • Leading process improvement initiatives identified
  • Development and monitoring leading indicators of validation execution performance. Development of actionable resolution plans where needed

The Person

  • 3rd level qualification in engineering or scientific discipline.
  • A minimum of 10 years experience in a cGMP regulated environment, with validation activities demonstrated successfully.
  • Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
  • Requires proven problem solving skills and the ability to adapt to new requirements.
  • Is results driven striving to meet all targets and standards.
  • Strong communication skills both verbal and written are required for the execution of this role.
  • Strong interpersonal skills are required.
  • This position is crucial in identifying validation requirements and developing actionable plans for successfully delivery across the network.
  • Ensures all procedures/policies and guidelines are adhered to.
  • Is a Global SME on all Process Validation issues and provides guidance on same.
  • Provide technical leadership to the company network and collaborates with key site stakeholders.
  • Responsible for the presentation of technical data to stakeholders to ensure prompt decisions.

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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