Sr QA Associate in Helwith Bridge - CV-Library

Team Horizon is seeking a Senior QA Associate for our clients aseptic manufacturing facility in Dublin. In this role you will be responsible for the inspection and release of primary packaging components. You 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.

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 company Policies.

* Perform all activities in compliance with 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

* 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