Senior QA Associate

Posted 02/05/2024 by Team Horizon

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Location:
City of Dublin

Team Horizon is seeking a Senior QA Associate (initial 12-month contract) for our client who are a global biopharmaceutical company in Dublin.

In this role will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.

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:

  • The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr. Associates may be asked to carry out additional work functions to support site continuous improvement activities.
    Incoming Quality Assurance Sr. Associate Key Responsibilities
  • Testing of primary and secondary components for use in the manufacture of aseptic products.
  • Sampling of Excipients and Drug Substance under Grade C conditions.
  • Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
  • Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
  • Provide training and advice to staff in relation to testing of components and packaging.
  • Actively participate in audits and their preparation.
  • Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
  • Write, review and approve Standard Operating Procedures in accordance with company Policies.
  • Perform all activities in compliance with company safety standards and SOPs
  • Support continuous improvement and Operational Excellence initiatives
  • Any other tasks/projects assigned as per manager’s request

What you need to apply:

  • Must Pass Eye-Tests have required for Visual Inspection
  • University degree. Engineering or Science related discipline
  • 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.

Type:
Contract
Contract Length:
12 Months
Job Reference:
3062
Job ID:
220356388

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