Role DescriptionAs a Quality Assurance Specialist you are responsible for selecting and qualifying contractors (CMOs, contract laboratories), drafting the required contracts and coordinating product specific documentation. Also are you working on maintenance and optimization of the quality management system (Deviations, CAPAs / Change Controls / SOPs / Document management).And last bur not least you help increasing and maintaining the quality awareness and GMP level of the organization.
ResponsibilitiesBut.... That not all. Within this position you also fulfill the following tasks:
...you ensure the design and optimization of (quality) processes to continue to comply with legislation and regulations. ...you lead quality improvement projects. ...you advise on and approve qualifications of complex equipment. ...you advise the organization during the product development and analytical development process because you as a QA Specialist think along with you when ...you draft documents such as risk analyzes, specifications, batch documentation, test documentation, validation documents, ect. Hereby you put the ICH guidelines into practice and you guarantee the GMP compliance of the final vaccine product.
RequirementsIt is a unique opportunity for an unique client. Do you dare to take on this challenge and be a part of a small QA team?
...You have a completed HBO / WO course in a relevant direction; ...You have knowledge of EU-GMP, FDA and ICH guidelines; ...You have at least 10 years of work experience in the field of QA within the (Bio)pharmaceutical industry ...You have knowledge of and affinity with (validation of) data management systems ...You have work experience in (bio) pharmaceutical product development and / or analytical development ...You have good command of English in speech and writing, preferably also command of Dutch;
Other informationBeside the requirements it is important to have the following competencies: 1. independence, 2. result-oriented, 3. flexibility, 4. verbal and written expression, 5. environmental awareness, 6. persuasiveness, 7. accuracy and 8. initiative.
Our client offers a good salary, with good secondary benefits.The salary is based on full-time employment (36-hour working week), excluding 8% holiday allowance and 8.3% end-of-year bonus. The job is for 12 months with the prospect of an extension.
Min €3.667 – Max. €5.450 (bruto)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Diana Prieto Reyes.