Role DescriptionIn this position you are responsible for compliance with both external and internal laws and regulations. You do this by keeping an overview, planning, reporting quality inspections, report audits, internal and external facility evaluations, system audits and data evaluations to support the projects (late stage development).
For example, you will be responsible for supplier management and will keep an overview of the validation and qualification activities related to production. You will participate in regulatory inspections, meetings and training. You also have the opportunity to introduce new ideas, develop SOPs and improve processes by establishing new procedures, techniques and guidelines.
Responsibilities- Supplier management of quality agreement suppliers - QA oversight of validation and qualification activities - Participation in regulatory agency inspections, (global) project team meetings and training activities - Initiate new ideas regarding improvement of business processes or procedures - Manage QA guidelines and develop SOPs - Lead process improvement with new procedures, techniques and guidelines - Prepare batches to facilitate technical release
Requirements- A master in Pharmacy or equivalent - At least 8 years experience in manufacturing or QA - Problem solving capabilities, proactive, eye for detail and good writing skills - Fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ria Bos.