Overview
Validation Engineer - Kerry
An opportunity is now available for a Validation Engineer with duties to include
Review of all IOQ documentation generated by C&Q vendor.
Preparation, execution and summary reports from PQ stage onwards for a full suite of equipment and instruments required for an aseptic fill finish facility incorporating Filling Line, Lyophilisers, Clean Utilities, Visual Inspection, QC Laboratories, Warehousing.
Support and review of documentation from Calibrations and Thermal Mapping Vendors.
Responsibilities:
Evaluation of validation requirements including areas of new equipment, change controls, new requirements.
Monitor status of projects and get updates where required, from a validation perspective.
Provide support to ensure that validation status reports are maintained through the issuing of monthly reports and regular validation group meetings.
Liaise with project managers to ensure project schedule is adhered to.
Assessment of current practices to ensure compliance with cGMP requirements.
Review/Implementation of procedures, reports, results etc. for compliance.
Review/ Implementation of both global and AICL, CSV documentation.
Responsible for the coordination of SDLC Documentation.
Review and approval of all project’s validation protocols plant wide.
Review and approval of project change controls.
Provide input into the development of company validation standards.
Arcadis | DPS Group is an Equal Opportunities Employer.
Recruitment Agencies: Please do not reply to this job advert.
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