Senior QA Associate

2022-06-16 16:11:462049-11-18Team Horizon
Job TypeContractor
LocationDublin
AreaDublinDublinIrelandDublin
SectorQuality
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2453
Job Views31
Description
Senior QA Associate – Team Horizon
We have an exciting opportunity available for a Plant Quality Assurance Senior Associate with our client who are a global biopharmaceutical company. In this role, you will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
 
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:
  • 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.
  • Participate in customer complaint investigations.
  • Provide 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 in Engineering or Science related discipline preferred.
  • Relevant experience (4 years+) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  • 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, protein formulation, vial and syringe filling.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.
 
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Darcy Ainscough-Denton
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