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QA Validation Specialist

Job description

 Are you a Validation Specialist? Do you want to join a team-based organisation, where colleagues are flexible, multi-skilled, and empowered to make decisions?

You will be responsible for the execution, review, and approval of validation activities in a GMP-regulated environment that is focused on implementing new manufacturing processes, equipment, cleaning and steaming, computer and laboratory systems as well as changes to existing equipment/processes.

Job Responsibilities

  • Develop validation plans and provide project management oversight for validation activities.
  • Execute validation activities related to the implementation of process, equipment, CSV, cleaning, procedures and practices.
  • Coordinate validation activities including cross- functional, multi- departmental teams.
  • Establish site validation policies through generation and implementation of validation master plans, SOP’s and guided documents.
  • Represent validation in multi-departmental meetings and project teams.
  • Participate in change control programs.

 

Job Requirements

  • Level 8 in Science or related technical discipline.
  • 3+ years experience in a cGMP environment.
  • A level of proficiency in process and cleaning validation.
  • Understanding of FDA & European regulatory requirements.
  • Proficient in technical summary report generation

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

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