Quality Data Associate Specialist (QAL2) – Blister
For our location in Haarlem we are looking for a Quality Data Associate Specialist (QAL2) – Blister.
Welcome to our team
Within our Quality Release department, we ensure that all our products are manufactured, processed, tested, packaged, stored and distributed according to the highest quality standards and applicable laws and regulations. Within this department, the Quality Release Blister team is part of a close-knit group of 11 colleagues. Together you support the entire Haarlem site in the area of quality assurance, product release and the introduction of new products. In this role you work closely with various disciplines and contribute directly to a reliable supply of medicines worldwide.
About the role
Our Quality Release team in Haarlem is looking for a Quality Data Associate Specialist, who plays a key role in managing and safeguarding quality data and processes. In this role you work on-site in an engaged team where quality and collaboration are central. You have a lot of contact with various departments and systems and ensure that quality guidelines are correctly applied and implemented. This gives you direct impact on compliance, product quality and patient safety.
Tasks and responsibilities
•You support departments in implementing changes to guidelines via, among others, Veeva, Veeva Registrations and Change Control processes
•You actively contribute to increasing quality awareness within the organization and act as a representative of Quality within various systems
•You participate in new product introductions, where you are responsible for the quality aspects
•You are Quality Assurance responsible for a number of products
•You check and approve master data (ZERT, ZERP and ZDSB)
•You review and set up Quality Standards within systems such as GLIMS and SAP
•You perform material control reviews and approvals in SAP
•You review Certificates of Analysis (CoAs), both manually and in SAP
•You lead, when necessary, investigations within deviation management
•You write and maintain QMS procedures
Your profile
•A Bachelor's or Master's degree in pharmacy, life sciences, process technology or chemistry
•At least 1 year of relevant work experience in a quality role in a GMP environment
•Experience with SAP, LIMS and Veeva is a plus
•Affinity with packaging technology and/or registration of medicines is a plus
•You are precise, results-oriented, flexible and work independently
•You have strong communication skills in both Dutch and English
We offer
Working at our organization means working together on health in an international working environment with dedicated colleagues. You get all the space to develop yourself and show who you are. You can also count on attractive terms of employment:
•A competitive salary
•35.5 vacation days
•8% holiday allowance and 3% year-end bonus
•Incentive Plan
•An excellent pension
•In-house sports facilities
•Various training modules
Employment status
Project Temps (Fixed Term)
Questions about this vacancy can be sent, together with the vacancy number and title, to: [email protected]. Applications can only be submitted via the website.
