Quality project associate - Life Sciences - M/F/X

About the role

As 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 environment

Key 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