Quality Assurance Analyst

  • Contract
  • Dublin

Website TPM05532

Summary:
A QA Associate is required for a biopharmaceutical company in South Dublin. The incumbent will be responsible for the inspection and release of primary packaging components. The successful candidate will serve as Quality point of contact for incoming inspection of primary and packaging components.

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’s policies.
  • Perform all activities in compliance with safety standards and SOPs.
  • Support continuous improvement and Operational Excellence initiatives.
  • Any other tasks/projects assigned as per manager’s request.

Qualifications & Experience:

  • 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.
  • Must Pass Eye-Tests required for Visual Inspection.
  • Demonstrated ability in problem solving and experience in managing Root Cause.
  • Analysis / Non-Conformance /Deviation investigations is preferred.
  • Experience working in aseptic operations, protein formulation, vial and syringe filling is preferred.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.