Team Horizon is seeking a CW QA Sr Associate (Senior) for our client based in Dublin. 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.
The Sr. Associate in Quality Assurance will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.
Why you should apply:
* This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
* Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
* 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 Amgen Policies.
* Perform all activities in compliance with Amgen safety standards and SOPs
* Support continuous improvement and Operational Excellence initiatives
* Any other tasks/projects assigned as per manager’s request.
What you need to apply:
* Basic Qualifications & Experience:
* 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.
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and proven abilities in decision making
* Strong organizational skills, including ability to follow assignments through to completion
* 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