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QA System and Validation

2 months ago

Dublin, Dublin City, Ireland Cpl Full time

The SK biotek Ireland Quality team at the Swords Campus is in search of a QA Systems & Validation Specialist on a 12-month contract, reporting to the Quality Manager.

Position Description:

  • Assessing changes for GMP compliance following site change control procedures for facilities, utilities, lab, manufacturing equipment, and control system changes.
  • Reviewing qualification and validation protocols, summary reports, and associated data to ensure compliance with regulations, SOPs, and specifications.
  • Qualifying premises, equipment, utilities, and computer systems.
  • Validating laboratory equipment.
  • Providing expertise in validation to ensure compliance with industry regulations.
  • Participating in cross-functional project teams as the quality assurance validation representative.
  • Reviewing and approving GMP design aspects of major capital projects.
  • Communicating with departments on site regularly to ensure timely change control approvals.
  • Ensuring quality systems compliance with industry standards.
  • Assisting in audit preparation.
  • Reviewing site periodic review and revalidation program.
  • Preparing, reviewing, and approving GMP documentation.
  • Interacting with functions on site such as Manufacturing, QC, Utilities, and Engineering.
  • Participating in projects directed by the Quality Systems & Validation Manager.
  • Strong interpersonal, communication, and presentation skills, along with good time management and organizational skills.

Minimum Requirements:

  • BSc/BEng in Chemistry, Engineering, or a science-related discipline with at least 3 years of pharmaceutical experience, preferably in a QA role.
  • Experience in change control, documentation management, and good manufacturing practices.
  • Knowledge of other site operations like QC, Operations, Engineering, and IT.
  • Some experience in Operational Excellence or project management is desirable.

Knowledge of regulatory requirements for Data Integrity and GMPs.

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