Quality Assurance Expert Global Pharma Manufacturing Site Budapest
Job Summary
Due to the expansion of our global pharmaceutical manufacturer partner we are in search of a Quality Expert(s) to join their quality team in Hungary. As a Quality Expert you will support the daily operation of quality tasks and also the improvement of the processess to maximaze this flagship sites performance and meet all quality requirements.
Responsibilities:
Should you be interested in the details of this vacancy please submit your CV.
Responsibilities:
- Supporting and educating the organization (number of manufacturing operations and research and development facilities) regarding GMP standards
- Collaboratein theinvestigation of deviations and OOSs OOTs OOEs
- WritingSOPs
- Supporting ongoing or starting investment projects in the area with the specific formulation of the relevant GMP criteria.
- Verification of production documentation from a QA aspect
- Participation in external / internal audits
- Development of QA processes to meet all quality standards
- Management of CAPAs discrepancies andchange control processes
- Prepare and supervise the annual Product Quality Report regarding the production and development areayou work with
- Coordinate CDMO projects from quality aspect
- Overview and apporve batch sheets
- Qualification as a pharmacist chemical engineer bioengineer chemist microbiologist biologist food engineer or any other equivalent degree
- Min. 2 years of professional experience in pharmaceutical quality assurance
- Strong understanding of GMP regulations
- Strong communication skills
- User-level computer skills
- Language skills: English intermediate (written and oral) and fluent Hungarian
- Experience with HP API products
- Experience inAPI and/or intermediate manufacturing is a plus
Should you be interested in the details of this vacancy please submit your CV.
Key Skills
- Test Cases
- SQL
- Quality Assurance
- Agile
- TFS
- Jira
- Software Testing
- Test Automation
- Cucumber
- QA/QC
- SDLC
- Selenium