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