Our client, a leading global biopharmaceutical organisation with worldwide operations, offers a comprehensive portfolio of biopharma products and services. Safety and quality are among their top priorities, as well as their mission to improve the health and well-being of people around the world. They have been in operation for over 100 years, and they produce and market innovative medicines. They are seeking a Qualified Person (QP) for their sterile manufacturing and packaging plant, reporting to the Technical Director.
Key responsibilities would include:
- To carry out product release for sterile manufacturing and packaging activities which can include quality batch documentation review and control, review and approval of controlled documents, including batch records and SOPs, quality performance reporting, and supporting KPIs.
- Support investigations, complaints, and projects.
- QA approval of visual inspection of Aseptic Process Simulation (APS)/Media Fill and Albumin product bags.
- Review and approval of change controls, CAPA, and deviations related to sterile manufacturing and packaging activities.
- Support product recall activities.
- Approval of product complaints investigations.
- Support annual product quality reviews.
- Act as a delegate for activities performed by the Technical Director.
- MSc in Industrial Pharmaceutical Science and eligible for Qualified Person status.
- 6-8 years of pharmaceutical industry experience and experience in sterile manufacturing.
- QP on licence for min 1 year plus.
- Ideal candidate will be a self-starter with a proactive, hands-on approach, possessing excellent interpersonal, decision-making, teamwork, and communication skills and will be capable of delivering to tight and often multiple deadlines in a dynamic and challenging work environment.
To discover more about this opportunity, apply now or contact Anita Osibuamhe at HRM on +353 1 6321870 for a confidential discussion.