About Your New Employer
- One of the world’s largest biotechnology companies engaged in the discovery, development and manufacture of innovative human therapeutics
- Aseptic operations facility with freeze-dry product (lyophilization) and liquid vial-filling capabilities
About Your New Job
- The Sr. Associate in Quality Assurance (QA) 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
- 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 Skills You Need
- 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.
- If you’re interested in hearing more, apply now by clicking the “Apply Now” button or call me, Niall Crosbie on + 353 896046664
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