About the roleAs a Quality project associate, you will ensure product quality and compliance within Quality Operations. The position involves overseeing product-related qualifications and validations, ensuring regulatory Chemistry, Manufacturing & Controls (CMC) compliance, and facilitating successful product launches. The specialist will act as an independent quality authority, focusing on validation, registration, and implementation processes. This is an opportunity to contribute to the excellence of product launches and regulatory compliance in a dynamic environmentKey responsibilities
Act as the quality authority for product-related qualifications and validations, ensuring compliance with cGMPs
Oversee process qualification, method validation, and component qualification for assigned products
Ensure regulatory CMC compliance by reviewing registration dossiers and site practices
Conduct data verification and QA review for marketing authorization filings and variations
Implement approved regulatory changes timely and accurately across different markets
Your Skills
Possess a Master's degree in a scientific discipline such as Pharmacy or Biomedical Sciences
Min 2 years of experience in the pharmaceutical or medical device industry
Excellent analytical and problem-solving skills in a quality assurance context
Exhibit strong oral and written communication skills in both Dutch and English
Maintain a thorough understanding of cGMP, regulatory guidances, and medical device regulations
