QA Validation Lead
Posted on Nov 23, 2019 by Anonymous
A permanent opportunity for a QA Validation Lead has arisen with one of our clients in Ireland. This is a very interesting and diverse opening, and a chance for an experienced all round Validation Specialist to join a team of passionate and highly skilled professionals. This role would provide the chance to be involved in the late stages of a Biologics expansion project, where the aim is develop products to address some of the world's most complex diseases.
In this position you would be responsible for the following -
* Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with Company policies, FDA, European cGMP and GAMP standards
* Generation/maintenance of the Validation Master Plans
* Generation/maintenance of Project Validation Plans
* Generation of validation protocols and final reports to cGMP standard
* Review / approval of all protocols and final reports
* Management of validation change control process
Required Skills and Experience -
* 3rd level qualification in engineering or scientific discipline.
* A minimum of 5 years' experience in a cGMP regulated environment, with validation activities demonstrated successfully.
* People Management experience is desirable
What's on offer -
* Competitive salary and above average benefits package as well as a relocation package for candidates who are considering moving
* Generous holiday allowance
* Supportive & encouraging work culture, where they put their people first
* Global opportunities & career progression
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