Excellent opportunity for a Senior QP (Qualified Person) to join a Biologics Leader in Ireland. The Snr Qualifed Person will be acountable for ensuring GMP production quality systems are in place adhering to all regulatory, cGMP and company requirements. The ideal person will have a biopharma background releasing biologics products as a commercial QP.
Overview of your responsibilities (full job description available on request):
- Act as site QP to be responsible of manufacturing release of DS/DP and participant in GMP production activities, such as process transfer, validation etc.
- Close monitoring the construction quality of GMP production.
- Work with functional department to create department SOPs and assure compliance with EU/FDA GMP regulations.
- Audit quality documents of functional department to assure data integrity and provide guidance from QA perspective
- Be responsible for setting up online DS/DP QA team
Knowledge, Skills and Experience Required for the Role:
- Preferable that the individual has qualification Degree in Vaccine and Biopharmaceutical Science
- Qualified Person as per EU Directive 2001/83/EC and have strong QA experience.
- Ideally 15 years working experience in vaccine/ biopharma or similar experience in a pharma/science background.
For a confidential discussion and more information on the role contact Courtney Russell
+353 (0) 71 9108062