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.
#J-18808-Ljbffr