Title: Senior Associate Quality Assurance
Location: Dun Laoghaire
The Sr. Associate in Quality Assurance (QA) will be an active member of the company's 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. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr. Associates may be asked to carry out additional work functions to support site continuous improvement activities.
* 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.
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.
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.