Quality Assurance Specialist (Senior) (
Independent Solutions
Dublin
Job Title Quality Assurance Specialist senior. About Company Our client based in Dun Laoghaire is seeking aQuality Assurance Specialist to join its expanding team. Duration of role 12 months. Summary Objective The QA Specialist will report to a QA Senior Manager and will be required to be a Subject Matter Expert in the Incoming Quality Assurance Area (IQA) area. Job Duties • Provide Subject Matter Expertise in relation to the testing of primary and packaging components for use in the manufacture of aseptic products. • Plan and perform routine analyses with efficiency and accuracy. • Approve IQA Incoming test results. • Manage the introduction of new techniques to QA Incoming, including method transfers, and validations. • Write protocols and perform validation and equipment qualification/verification. • Assume ownership and/or oversight of change control and NC/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely. • Write, review and approve Standard Operating Procedures in accordance with Amgen Policies. • Participate in customer complaint investigations with suppliers of components and packaging. • Provide training and advice to staff in relation to testing of components. • Actively participate in audits and their preparation. • Evaluate practices for compliance and operational excellence improvement on a continuous basis. • Perform all activities in compliance with Amgen safety standards and SOPs. Requirements Skills andexperience Novisa processing A primary component is a vial, a syringe, or stopper in direct contact with the product. A secondary packaging component is something like a printed leaflet or printed carton. Basic Qualifications. • University degree. Engineering or Science related discipline preferred. • Relevant experience (8yrs ) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Benefits This job originally appeared on RecruitIreland.com.
1960 days ago