Qa Snr Associate

3 weeks ago

Dublin, Dublin City, Ireland Life Science Consultants Full time
LSC have a great opportunity for a QA Snr Associate to join a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 4+ years of experience in construction management/engineering within the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project 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 NC and CAPAs for closure ensuring compliance with appropriate documentation Provide training and advice to staff in relation to testing of components and packaging Review c GMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation ABOUT YOU - ARE YOUR SKILLS A MATCH? Must Pass Eye-Tests required for Visual Inspection 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.
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.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1 G or a Stamp 4 visa.
Please note that we are unable to provide visa sponsorship.
Thank you for your understanding.
Apply via this advert or contact Grinne Hodnett on if you have any more questions about this opportunity Skills: GMP Aseptic SOP Compliance CAPA Root cause non-conformance

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