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QA Associate

Job description

My client the world leader in developing and commercializing innovative biopharmaceuticals is looking for a QA Associate to join their ever-growing team.

You will be supporting site quality systems, manufacturing operations, site start-up, and inspection readiness.

Job Responsibilities

  • Prepare the site for GMP operations.
  • Review and approve electronic and paper production batch records.
  • Daily presence and support of the manufacturing floor.
  • Release of raw material for production.
  • Act as a support for the Technology Transfer of new product (raw materials and supplier qualification)
  • Review and approve SOPs and master batch records and Change Control
  • Review and approve Trackwise deviation and investigation
  • Assist with regulatory inspections.

Job Requirements

  • Level 8 in Science or in a technical discipline (physical, engineering chemical, or biological sciences) is required.
  • 3+ years relevant experience in a cGMP regulated manufacturing environment.
  • Experience in supporting manufacturing operations. Batch record review is highly desirable
  • Excellent communication skills with the ability to support cross-functionally.
  • Ability to comprehend technical information.

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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