Senior Quality Engineer

  • Reference: CJqualityBiopharma
  • Job Type: Temporary
  • Location: Cork, Nationwide
  • Category: Science, Pharmaceutical & Food

Job Responsibilities

• To provide consultative support on quality related issues to project teams. 
• Participate in cross-functional teams as required. 
• Ensuring all production steps have been performed and verified, that all limits and specifications have been met. 
• QA support for qualification activities – review and approve equipment/utility qualification documentation from design to post-execution. 
• Review/approval of technical documentation. 
• Review/approval of production instructional documentation (SOPs and batch records) to ensure they are up to date, compliant, and support efficient production, 
• Carryout cGMP compliance area walk-throughs of Manufacturing Operations as required. 
• Participate in the internal audit programme as required. 
• Maintain tracking system for project document review status. 
• Review event/investigation reporting including support of Manufacturing Operation teams with investigations and resolution of discrepancies. 
• Co-ordinate and review change controls as required. 
• Perform completion of batch disposition packs within required timelines /Work with site QPs to ensure timely issue resolution to final disposition. 
• Review of regulatory documentation 
• Assist in the creation and maintenance of up to date QA policies, SOP’s and reports. 
• Assist in the development of training curricula and records for the QA Operations Group. 
• Perform and assist with additional duties as may be directed by the QA Ops Lead. 


• B.Sc. degree in biology, chemistry, or other related technical degrees. 
• Min 4 years working experience in a pharmaceutical manufacturing environment, preferably in a quality assurance or quality control role. 
• Previous QC/QA and/or pharmaceutical experience in a GMP or GLP facility. 
• Excellent communication and interpersonal skills. 
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

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Eloísa Ruiz

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  • Eloísa Ruiz
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  • 0214911066
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