Senior Quality Assurance Associate
Shift days
RK5309
Contract 12 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.




The Sr. Associate in Quality Assurance will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components. Reporting to a QA Manager, they will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.




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 deviation’s 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 with suppliers of components.
• Provide training and advice to staff in relation to testing of components and packaging.
• Actively participate in audits and their preparation.
• Review and approve cGMP records (e.g., WO, JP, GDMS, Deviation, 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 safety standards and SOPs
• Support continuous improvement and Operational Excellence initiatives
• Any other tasks/projects assigned as per manager’s request.

• University degree in a Science-related discipline
• 4+ years experience working in the pharmaceutical or biotechnology industry
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations
• Experience working in aseptic operations, protein formulation, vial and syringe filling.