QA Validation Lead
· Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
· 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.
· 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
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists