Cache of job #13865450

Job Title

EU Validation Coordinator

Employer

Fastnet The Talent Group

Location

Cork

Description

Fastnet The Talent Group are currently recruiting for an EU Validation Coordinator with a leading Biopharmaceutical client. flexible location across Cork, Dublin and Sligo. Permanent Role. QA EU Validation Coordinator responsible for coordinating the development and maintenance of the company's validation program in compliance with all applicable regulatory 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. This role can be based in Ireland (Santry, Sligo or Cork), Germany or Italy. Key Responsibilities: 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 compliance 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. Leading process improvement initiatives identified. 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. 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. Responsible for the presentation of technical data to stakeholders to ensure prompt decisions. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

Date Added

2233 days ago

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