CMC QA EU Validation Lead

  • Reference: CJ47215
  • Job Type: Permanent
  • Location: Cork, Cork City, Munster
  • Category: Engineering, Technical & Manufacturing

Role Responsibilities:

  • You will develop and implement global strategic initiatives to ensure New Product Introduction PPQ’s are executed RFT.
  • You will co-ordinate the 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.
  • Collaborating with partners including Global and Site Operations and QA, Science & Technology and Research & Development to drive broader network efficiency will be a key element of this role
  • You will review/approve Project Validation Plans associated with New Product Introductions. in addition to ensuring validation protocols and final reports associated with New Product Introductions is to cGMP standard
  • Review / Approval and Oversight of validation change control processes across all sites with New Product Introductions
  • You will lead process improvement initiatives identified while developing and monitoring leading indicators of validation execution performance.
  • As a result, you will develop actionable resolution plans where needed

Education & Experience:

  • 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. 

 

For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email eloisa.ruiz@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Eloísa Ruiz

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  • Eloísa Ruiz
  • Recruitment Consultant
  • 0214911066
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