Up to 110,000 €
7 months ago
Head of Quality Assurance (QA)
A global leading pharmaceutical company is in the process of opening its first biologics site in the Republic of Ireland. As a result, they are looking for a highly experienced QP with biologics or aseptic experience to join them on a permanent basis to build out the QA team from scratch.
The role involves but isn't limited to:
- Lead the QP & QA Operations group (once in place), including batch release, product performance, Data Analytics, new products introduction (NPI), and interface with HPRA and FDA.
- Ensure product manufacture is in accordance with Good Manufacturing Practice and meets requirements of our patients, Regulatory Authorities (FDA, HPRA etc) and of the company
- Partner with internal and external Regulatory groups, FDA, HPRA etc while liaising with operations, technical operations, science & technology teams in relation to product filing support.
- Have responsibility for the oversight of product performance process, product quality Review, complaints and product track and trend
- Ensure compliance with all processes and procedures while maintaining the Quality Risk Management (QRM) program on site
If you are an experienced QP who is looking to get into management this could be the perfect opportunity for you.
Any questions, don’t hesitate to get in touch!