This leading global Biologics organisation are a CMO with a great product pipeline. Their expansion into Ireland will result in the recruitment of approximately 700 construction staff during the build phase, with circa 400 permanent employees to be hired over the next 3 years for the facility. Once operational, the site will be responsible for the contract manufacturing of large molecules, specifically, cell culture derived product for client organisations. There are 2 products already in the pipeline for the site in 2021 when it is expected to be fully operational and FDA approved.
The company are investing €325 million in a state-of-the-art greenfield manufacturing plant which will deploy multiple single-use bioreactors for commercial bio-manufacturing. The site has been designed to run continuous bioprocessing, a next generation manufacturing technology, which will be implemented for the first time on this campus.
Reporting to the Associate Director of QA Supplier Audit, the QA Auditor will participate in a variety of audits and inspections, both external and internal while supporting regulatory compliance and adherence to cGMP.
Some of the essential duties and responsibilities of the QA Auditor are:
- Conduct audits as directed by AD Supplier Audit. This will include a variety of audits both external and internal, including vendors and suppliers, clients and regulatory inspections.
- Complete written reports and findings in a timely manner.
- Drive closure of CAPA's and any associated actions.
- Act as a Quality point of contact for vendors and suppliers.
- Maintain the audit schedule and approved suppliers list.
The successful candidate will have the following:
- Experience within a GMP facility, preferably within the Biopharma/Pharmaceutical industry.
- 3+ years' experience of direct auditing.
- Preferably a degree qualification within a science-related discipline.
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.