In this role you will support the QP Synthon BIO with relevant quality issues. You will prepare batch release for the QP. Furthermore, you will participate in CMC meetings to support product development within Synthon BIO. Your responsibilities include:
Releasing drug Intermediates and preparing batch release in close cooperation with QP.
Participating in CMC meetings.
Reviewing and approving QA documentation such as validation protocols and reports, risk assessment, procedures, work instructions, etc. Providing an excellent advisory service to production and R&D departments (QbD) for QA related systems.
Participating on behalf of QA in the setup of new quality related systems from a biopharmaceutical point of view.
Advising Synthon BIO on the implementation of new and revised guidelines (Eudralex, ICH, CFR,...)
Writing, maintaining, approving procedures for Synthon BIO, when needed.
Performing internal and external audits and support on critical external audits from customers and/ or authorities.