Quality Assurance Reviewer
Employer · Abacus Medicine Group
Quality inspector
Production engineer
Other engineering technicianFull-timeBudapest
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.
Tasks
- 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
Conditions & benefits
Hybrid modelThe team operates in a hybrid model.International communityBe part of an international community of people who care.
Requirements
- Hold 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