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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Marthe Berlanger
HR & Talent Consultant Life Sciences
0032476635063