Pauwels Consulting
EN
Quality Project Associate
Antwerp
Life Sciences - Validation and Qualification
Master
Work experience: 0-3
Reference number: 90561

Join a dynamic team dedicated to ensuring the highest quality standards within a thriving pharmaceutical environment. This role offers a unique opportunity to contribute to product launches and regulatory compliance, making a tangible impact on public health.

As an ideal candidate, you are a detail-oriented Quality Assurance Consultant with a passion for upholding quality and compliance within the pharmaceutical or medical device sectors. Your analytical mindset and problem-solving skills will be essential in driving successful product qualifications and validations.

  • You act as an independent quality authority for product-related qualifications and validations.
  • You ensure compliant and right-first-time product launches within Quality Operations.
  • You pursue regulatory CMC compliance regarding plant processes and regulatory filings.
  • You validate documents such as process qualifications, method validations, and filter validations.
  • You participate in the verification and QA review of marketing authorization filings and respond to health authority queries.
  • You ensure correct and timely implementation of approved regulatory changes on site.
  • You perform compliance checks of registration dossiers versus site practices.

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 sector or medical device industry.
  • You possess knowledge in Quality Assurance or Compliance and in regulatory affairs (CMC).
  • You have a strong quality mindset.
  • You exhibit excellent analytical and problem-solving skills.
  • You are an excellent communicator, both orally and in writing.
  • You demonstrate scientific knowledge and skills.
  • You are fluent in Dutch and English.
  • You have excellent knowledge of cGMP, regulatory guidance, and relevant medical device regulations.

What do we offer?

  • Enjoy a competitive salary package with extra perks that recognize your talent.
  • Advance your career with a clear growth path, coaching, and mentoring to support you.
  • Thrive in a dynamic and supportive environment where you can truly make an impact.
  • Work when and where you perform best, ensuring an optimal work-life balance.
  • Choose a flexible transport solution, from a company car to a public transport subscription.
  • Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
  • Grow your skills with external courses and our in-house Pauwels Academy.
  • Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
  • Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.

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