This global pharmaceutical leader focuses on improving patient's lives by identifying, developing, and commercialising meaningful products that address unmet medical needs. Since their founding, they have focused on putting the patient first and this remains their priority as they continue to develop, acquire, and commercialise new treatment options for patients with challenging conditions that no one else is tackling. Currently employing over 40,000 staff globally, with offices in the U.S. and Europe, they are a continually growing company with a broad portfolio and a very healthy pipeline. This organisation has an incredible manufacturing footprint here in Ireland and one of their plants is currently in need of a Primary QP to join their operation.
Key responsibilities would include:
Manage the day-to-day administration of the Site batch release program and provide leadership and mentoring to other QPs.
Act as Primary QP with responsibility for release of pharmaceutical/combination products to the market in accordance with guidelines of Annex 16 of EU GMP guide.
Responsible for the release of medical device finished products to market as per relevant approved procedures.
Allocate resources based on the quality system priorities and corresponding business needs.
Establish high standards for performance management and accountability to achieve quality and organisational objectives.
Assign project work and review workload for all direct reports. Assist staff with their responsibilities establishing goals and setting objectives that will increase their knowledge and skills level.
Demonstrate commitment to high standards of GMP compliance and product quality.
Foster a good working relationship within the QA Department and with all other departments.
MSC in Industrial Pharmaceutical Science and eligible for Qualified Person Status.
5-10 years' experience in Pharma or Bio Sterile manufacturing and/or Med Device / combinational product manufacturing.
QP on licence for min 2 year +.
Ideal candidate will have strong people management skills, be self-motivated, work well in a fast-paced environment and have experience with the relevant health authorities (HPRA, FDA).
To discover more about this opportunity, apply now or contact Déanna Healy at HRM on +353 87 636 9263 for a confidential discussion.