Our client is a leading global biopharmaceutical organisation who are searching for a Senior Associate Technical Writer to join their expanding South Dublin workforce. This individual will be responsible for leading, coordinating, contributing to and undertaking activities relating to manufacturing Deviations, Corrective/Preventive Actions and Change Controls.
The main responsibilities of this role will include:
- Manage all quality system activity associated with manufacturing Deviations, CAPA Records and change controls
- Lead all root cause analysis studies implementing improvements and corrective actions
- Document control management- Initiate, revise, and approve engineering/manufacturing procedures. Act as document owner.
- Ensure timely completion of Deviations, CAPAs and change controls utilising the appropriate procedures and Quality Management Tracking System (QMTS)
- Support the execution of manufacturing/quality systems such as non-conformances, change controls, utilities validation, procedures, training, and new product introductions
To be considered for this position you will possess:
- A third level qualification in Biology/Life Science/Engineering or equivalent
- 3-5 years' experience in a similar role in the pharmaceutical sector
- Detailed technical understanding of manufacturing/engineering unit operations
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
- The following competencies: planning/organisation, problem-solving, communication, teamwork, flexibility, coaching and motivating
To discover more about this opportunity, apply now or contact Helena Boyle on (01) 6321870/0873360953 for a confidential discussion.