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Validation Specialist

  • Division: Science & Pharma
  • Contact Email: colin.byrne@collinsmcnicholas.ie
  • Job Ref: 24190

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