Quality Assurance Senior Associate

IrishJobs

Dublin, Dublin, Ireland

Dublin, Dublin, Ireland

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À propos

LSC have a great contract opportunity for a Quality Assurance Senior Associate to join a South Dublin based Biopharmaceutical company. If you have 4 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! About the Project - 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. 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. Education/ Experience: University degree in 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. 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. About you - Are your skills a match? Strong organizational skills, including ability to follow assignments through to completion. Excellent written and verbal communication skills. Experience working with dynamic cross-functional teams and proven abilities in decision making. Must Pass Eye-Tests required for Visual Inspection. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Kathy Gillen on if you have anymore questions about this role! Skills: Pharmaceuticals Quality Assurance Aseptic Testing Documentation Audits

TLNT1_IJ

Dublin, Dublin, Ireland

Compétences linguistiques

English

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