Qualified Person at Abacus Medicine Group

Alkmaar, North Holland, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

19 Mar, 26

Salary

0.0

Posted On

19 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Good Manufacturing Practice, Batch Release, Documentation Management, Internal Audits, External Audits, Compliance, Pharmaceutical Production, Team Collaboration, Continuous Improvement, Problem Solving, Attention to Detail, Communication, Regulatory Standards, GMP Courses, MS Office

Industry

Pharmaceutical Manufacturing

Description

As a Qualified Person (QP), you hold the final responsibility for certifying and releasing medicines, ensuring they meet strict regulatory standards before reaching the market and patients in need. Your expertise guarantees compliance, safety, and trust in every batch produced by Abacus. This role is vital for patient safety —without a QP, medicines cannot be certified for market release. If you're passionate about quality and making a real impact, we want you on our team! Get a glimpse of our world Our international team consists of colleagues not only in the Netherlands but also in Germany, Denmark and Hungary. You will be a part of dedicated team located in Alkmaar that mission is to protect public health and ensuring excellence at Abacus! Are you ready to embark on this journey with us? Your main responsibilities include: Verify Batch Journals completeness before release Ensure compliance with Good Manufacturing Practice (GMP) Evaluate, approve, and archive manufacturing documentation & Batch Journals Prevent distribution of non-compliant products Release medicine batches for clinical use Maintain and manage the quality management system Ensure safe storage of Batch Journals & retention samples (Co-)coordinate site inspections by authorities Approve manufacturing & GMP documents Conduct internal & external audits at contract manufacturers Oversee and approve deviations, CAPAs, and Change Controls Fuel for your success in the role We imagine that you have: WO degree, in the field of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology (according to article 51 of the European Commission’s directive 2011/83/EC) Required to have passed all the offered GMP and GDP courses Fluent in both Dutch and English is essential Experience in a Pharmaceutical Production environment is desirable Minimum 6 months of GMP experience required for batch release eligibility Dedicated to quality, continuous improvement, and excellence. Basic knowledge of and experience with MS Office programs Would you like to know more about us? If you want to apply for the position, please follow the link and attach your CV and cover letter. If you have any further questions about the role, please do not hesitate to contact the hiring manager, Sander Griep, Head of Site QA NL & Principal QP on sander.griep@abacusmedicine.com. Interested? Follow us on Instagram and LinkedIn and get an insight into everyday life at Abacus Medicine. For job openings, check our Career page. Moving Healthcare. Moving You. In Abacus Medicine Group, you’ll experience the power of Moving Healthcare. With our change mindset, we're moving the industry and improving healthcare as we broaden access to medicine. But it's not just about moving healthcare, it's about Moving You. You’ll be part of a caring community of more than 1,300 people across the world. With us, you will be valued, empowered, and have a direct impact on driving change. Let's access the future of medicine and make a difference together. Your move.

Responsibilities

The Qualified Person is responsible for certifying and releasing medicines, ensuring compliance with regulatory standards. Key tasks include verifying batch journals, approving manufacturing documentation, and preventing the distribution of non-compliant products.