QA Reviewer

ABACUS MEDICINE; Netherlands; On-site; EUR 32,000 - 42,000; Full time

Job summary

ABACUS MEDICINE in Alkmaar is seeking an entry-level QA Reviewer to ensure medicinal products are reviewed accurately and in full GMP compliance before release.

You will join the Quality Assurance team and collaborate with QA Reviewers and Qualified Persons to support timely, compliant product release across EU sites.

Qualifications

• At least a MBO working and thinking level or equivalent.
• This is an entry-level position, experience within a regulated or pharmaceutical environment is an advantage, but not required.
• Basic knowledge of GMP principles and an interest in pharmaceutical quality assurance and batch review processes;
• Strong communication skills in English, both written and verbal; Dutch is considered an advantage;
• The ability to work independently, manage your own responsibilities and prioritize tasks effectively to meet deadlines;
• A highly accurate and detail-oriented approach, ensuring documentation is reviewed thoroughly and consistently.

Responsibilities

• Review production documentation to ensure medicinal products have been manufactured and repackaged in accordance with the Master Batch Journal, the Marketing Authorisation and applicable GMP regulations.
• Review completed Batch Journals, verify documentation and photo samples, prepare batches for Qualified Person release and ensure all review activities are completed accurately and within the required timelines.
• Contribute to maintaining and continuously improving the review process; communicate with internal stakeholders to resolve deviations and support colleagues with batch documentation questions.
• Assist in updating Quality Management System documentation, approve reprocess forms and ensure Batch Journals are administered and archived correctly.
• Collaborate across departments and sites to ensure an efficient and compliant release process.

Skills

English communication

Dutch language (advantage)

Education

MBO level or equivalent

Job description

Drive meaningful change
Are you quality-driven, detail-oriented and eager to contribute to patient safety? We are looking for a proactive Quality Assurance (QA) Reviewer who ensures that medicinal products are reviewed accurately and in full compliance with GMP requirements before they are released to the market. In this role, you will play an important part in safeguarding product quality and ensuring patients receive safe and compliant medicines.

Get a glimpse of the team

You will be based in Alkmaar and become part of the Quality Assurance department, working alongside QA Reviewers, QA Officers, Qualified Persons and the Team Lead QA Review. Currently the QA reviewing team consists of 5 colleagues. You will also collaborate closely with colleagues from Operations, Repackaging, Supply Chain and our Quality teams in Denmark and Hungary to ensure an efficient and compliant review and release process.

Your main responsibilities

As QA Reviewer, you are responsible for reviewing production documentation to ensure medicinal products have been manufactured and repackaged in accordance with the Master Batch Journal, the Marketing Authorisation and applicable GMP regulations. You review completed Batch Journals, verify documentation and photo samples, prepare batches for Qualified Person release and ensure all review activities are completed accurately and within the required timelines.

Alongside your operational responsibilities, you contribute to maintaining and continuously improving the review process. You communicate closely with internal stakeholders to resolve deviations, support colleagues with batch documentation questions, assist in updating Quality Management System documentation, approve reprocess forms and ensure Batch Journals are administered and archived correctly. By collaborating across departments and sites, you help ensure an efficient and compliant release process.

Fuel for your success in the role, we imagine you have:

• At least a MBO working and thinking level or equivalent;
• This is an entry-level position, experience within a regulated or pharmaceutical environment is an advantage, but not required;
• Basic knowledge of GMP principles and an interest in pharmaceutical quality assurance and batch review processes;
• Strong communication skills in English, both written and verbal; Dutch is considered an advantage;
• The ability to work independently, manage your own responsibilities and prioritize tasks effectively to meet deadlines;
• A highly accurate and detail-oriented approach, ensuring documentation is reviewed thoroughly and consistently;

Would you like to know more about us?

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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 1,800 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.