Quality Assurance Reviewer
The Quality Assurance Reviewer's main responsibility at Abacus Medicine is to ensure the completeness of production documentation in accordance with global and local relevant legislation and marketing authorization.
This position operates within the quality assurance systems of the company, assuring all necessary documentation is prepared during production processes and are efficiently forwarded to release processes.
Drive meaningful change!
As a QA Reviewer, your tasks will include, but are not limited to:
Check and verify that all relevant documentation for production processes are present and fully comply with GMP regulations and internal procedures.
Maintain continuous and clear communication with relevant internal departments and Qualified Persons (QPs) to resolve documentation issues.
Track production orders effectively from the end of production through to the final release phase
Identify documentation mistakes and cooperate closely with the relevant departments to ensure timely corrections
Manage and prioritize daily workload effectively to ensure all operational and product release deadlines are consistently met
Hold or suspend production orders (PO) based on well-defined reasoning
The team You shall work with:
Currently, the Hungarian team consists of 12 reviewers, while the Dutch team has 6 reviewers.
The team operates in a hybrid model. You shall report to the QA Review Team Lead.
About You, our future colleague:
Holda a Bachelor’s degree in pharmacy, Health, Life Sciences, or a similar field OR
Has 3+ years of experience within Quality Assurance. (ideally in a GMP-regulated environment).
Has English B2 language knowledge both written and spoken.
Has basic GMP knowledge and understanding of documentation structures.
Is strong at formal checks and error-detection, in line within structured documentations.
Holds strong communication and collaboration skills to work effectively with other departments and QPs.
Is good at time-management and workload prioritization to consistently meet release deadlines.
Has exceptional precision and high attention to detail
Be part of an international community of people who care!
Interested?
If you want to apply for the position, please follow the link and attach your CV.
Would you like to know more about us?
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 1,750 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.
- Department
- Quality Assurance
- Role
- Coordinator, Quality Assurance Review
- Location
- Budapest - Kerepesi út 52
- Remote status
- Hybrid
- Employment type
- Full-time