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Employers

Senior QA Associate - (Plant Quality Assurance), Dublin

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Location:

Dublin, Ireland 

Job Category:

Biotech/Pharma, Science
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EU work permit required:

Yes
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Job Reference:

1702

Job Views:

124

Posted:

30.04.2020

Expiry Date:

14.06.2020
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Job Description:

We are seeking applications for a Senior QA Associate - (Plant Quality Assurance) to join our client at their state-of-the-art aseptic manufacturing facility in Dublin.

Why you should apply:

  • This is an exciting opportunity to be a core member of the site Quality Assurance team.  You will be required to serve as Quality point of contact for manufacturing operations.

 What you will be doing:

  • Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
  • 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 NC1s and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
  • 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. Science or Engineering related discipline preferred.
  • University degree. Engineering or Science related discipline preferred.
  • Relevant experience (4 yrs +) 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 issue
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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