Description:
PE Global is currently recruiting for a Senior QA Associate on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.
This is a 2-cycle shift position.
* Week 1 - Early shift: 07:00 to 15:00, Monday to Thursday; 07:00 to 14:00, on a Friday
* Week 2 - Late shift: 14:30 to 10:30 Monday to Thursday; 13:30 to 08:30 on a Friday
Overview:
* 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 Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.
Role Responsibilities:
* 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
* Participates in customer complaint investigations with suppliers of components.
* 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 Policies.
* Perform all activities in compliance with safety standards and SOPs
* Support continuous improvement and Operational Excellence initiatives
Skills required
:
* 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on or alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***