R&D QA Engineer Biopharma Budapest
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Our client is a European biopharma that develops manufactures and commercializes biological substances. Due to the expansion of the production site in Hungary we are looking for a QA Engineer to join their team of 3 people. The purpose of the newly formed position is to bring GMP approach to the laboratory and improve the GLP/GMP relay.
As a QA Engineer you will play crucial role in supporting growth by:
Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.
As a QA Engineer you will play crucial role in supporting growth by:
- Supporting maintaining and improving the quality system related to the production
- Ensuring that the method validation stability and transfer studies are conducted in accordance with applicable regulations and quality standards
- Reviewing SOPs to Industrial Development in accordance with GMP and internal standards and releasing documentationof R&D related to production activities
- Review the batch records and release development products for Industrial development studies
- Participation in investigations related to development products as requested
- Participation in trend analysis of investigation of deviations and complaints related to development products as requested
- Supportinternal/external audits and execute requested CAPAs
- MSc in Life Science related topic (pharmacy biology biotechnology etc.)
- 3-5 years relevant professional experience in quality assurance (GMP)
- Excellent knowledge in MS office applications
- Fluent in English (both oral and writing)
Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.
Required Experience:
IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
