In this role you act as a Qualified person, you are responsible for releasing finished drug product lots while ensuring compliance with the requirements of the marketing authorization and good manufacturing practices.
As a Specialist Plant QA, you provide guidance and direction to Production, Maintenance & Engineering and Quality staff regarding compliance with quality standards and procedures.
You partner daily with production and engineering staff to support, enable and improve the production process
You partner with production staff in performing risk analysis and the establishment of quality limits and requirements
You own, review and approve production and plant QA related documents (e.g. SOPs, Forms, Training)
You review and approve deviations and CAPA, initiate and own as needed.
You perform impact assessment as part of change controls impacting production or QA processes
You review and approve production equipment maintenance work orders
You review and approve test protocols before use in production
You perform GMP compliance checks in production
You participate in internal audits and lead as appropriate
Participate in regulatory inspections and partner audits
You assist in development and delivery of GMP training for QA and production staff
You lead and participate in Plant QA related projects/global QA initiatives as needed
You lead and assist in various investigations as needed
You assist in validation activities as needed including review and approval of validation documents
Who are we looking for?
Master’s in science in Pharmacy or equivalent
Knowledgeable, skilled and eligible to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person).
Thorough knowledge of the processes involved in clinical and commercial manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation
Acquired practical experience in Good Manufacturing Practice (GMP) ideally in a Secondary Packaging manufacturing setting
Fluent in English
What does QbD offer you?
A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
Real investment in people through education and fun events
A competence development model focused on your personal ambitions
An attractive salary package
Interested? Apply now by sending us your CV and motivation.