QA Complaints Associate
What are your responsibilities?
- Complaints handling (including performing assessments) in accordance with internal procedures, regulatory guidelines and business performance objectives.
- Initiate and own product quality complaints, Safety quality investigations and product security investigations for commercial and/or clinical products
- Perform assessments in support of complaint investigations (e.g. batch record review, reserve sample inspection, Return sample inspection and Safety Features verification)
- Partner with corporate product quality surveillance, assessors from other sites and contracted partners to resolve product complaint investigations
- Partner with affiliates in country and intake call centers on call intake procedures and complaint investigations
- Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements
- Assist in Breda projects and improvement efforts as needed
- Provide training to affiliate staff on complaint handling procedures and performing investigations/assessments
- Initiate and own QA Non Conformances/CAPAs as needed
- Participate in site regulatory inspections of complaint handling process and in audits (internal and third party) as required.
Who are we looking for?
- Master's degree or Bachelor’s degree in Life Sciences
- Typically 3 or more years of related professional experience
- Fluent in English and Dutch language.
- Related professional experience
- Experience in Quality Assurance, including handling product complaints investigations
- Experience in pharmaceutical industry
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.