Join a dedicated team focusing on pharmaceutical excellence, where your contribution will ensure compliant product launches and quality assurance in the industry. This role promises to immerse you in significant responsibilities tied to validation and regulatory compliance.
As the ideal candidate, you are a knowledgeable
Quality Assurance Professional
with a commitment to excellence in the pharmaceutical or medical device industry. If you have a background in Quality Assurance, regulatory affairs, and a passion for ensuring product integrity, we encourage you to explore this opportunity.
* You act as the independent quality authority for product qualifications and validations.
* You ensure compliant and right-first-time product launches within Quality Operations.
* You maintain regulatory CMC compliance for plant processes in alignment with regulatory filings.
* You serve as the quality authority for qualification and validation documents.
* You perform data verification and QA review for marketing authorization filings and variations.
* You conduct compliance checks of registration dossiers against site practices.
* You ensure timely implementation of approved regulatory changes at the site.
What are we looking for?
* You hold a
Master's degree in a scientific discipline
(e.g., Pharmacy, Biomedical Sciences, Bio-engineering).
* You have at least
2 years of relevant experience
in the pharmaceutical or medical device industry, or equivalent experience through a PhD, with a focus on Quality Assurance or Compliance.
* You possess a strong understanding of
cGMP
and relevant regulatory guidances.
* You are pragmatic in your approach to problem-solving.
* You have excellent analytical skills and can tackle complex challenges effectively.
* You are an effective communicator with strong oral and written skills.
* You are fluent in
Dutch
and
English
.