QA Senior Associate

2 weeks ago

Dublin, Dublin City, Ireland TEAM HORIZON Full time

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Team Horizon is seeking a QA Senior Associate (Senior) on an initial 12-month contract for our Dublin based client who are a global leader in the field of biotechnology.

Why you should apply:

  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.
  • Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

  • Perform all activities in compliance with safety standards and SOPs.
  • Write, review and approve Standard Operating Procedures in accordance with Policies.
  • Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
  • Review and approval of deviations for closure ensuring compliance with appropriate documentation.
  • Participates in customer complaint investigations.
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
  • Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
  • Review and approve cGMP records ensuring compliance with appropriate documentation.
  • Support continuous improvement and Operational Excellence initiatives.
  • Any other tasks/projects assigned as per manager's request.

What you need to apply:

  • University degree. Engineering or Science related discipline preferred.
  • Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry.
  • Excellent written and verbal communication skills.
  • Experience working with dynamic cross-functional teams and proven abilities in decision making.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
  • Experience working in aseptic operations an advantage
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