Our client, a leading global healthcare company based in Cavan, is recruiting for a Validation Specialist for a 6 month contract.
Primary Function / Goals / Objectives
·Follow all Environmental, Health and Safety Rules and Regulations in the plant.
·Report any current or potential hazards to your manager immediately.
·Wear the correct Personal Protective Equipment (P.P.E.) at all times. Consult the appropriate SOP where required.
·This function has the responsibility for reviewing all SOP’s for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP.
·The Validation Specialist will be part of the Materials Team reporting to the Project Manager.
·Manage and co-ordinate the Validation Change Control System, Validation Master Plan and associated schedule and all related documentation.
·Support QA IT Systems (M-FILES) through which Validation Change Control is documented. This also involves the development and support of plant SME’s and general users.
·Responsible for the creation of validation packages such as Validation change Request, System Risk Classification, Failure Mode Effect Analysis etc. and write-up of all validation protocols and packages.
Education Required
·Bachelor’s Degree in Pharmaceutical Science, Food Science, Dairy Science or related Engineering qualifications. Food Microbiology or Food Chemistry would be desirable however, not essential.
Knowledge
·It is an advantage to have knowledge on Validation and CAPA Policies or FDA regulations in relation to validation.
·Knowledge of Software Validation preferred.
·Project Management Skills or experience with Project Management is essential.
·Excellent interpersonal skills and very good computer literacy.
For a confidential discussion and more information on the role, please contact Colin Byrne.
colin.byrne@collinsmcnicholas.ie
071-91-40255