CROMA-PHARMA is an internationally active, family-owned pharmaceutical Company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.
We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.
We are expanding our team and therefore looking for a Release Responsible.
- Area-specific responsibility
- For the batch release of medical and cosmetic products
- To ensure compliance with current GxP and medical device requirements
- For the maintenance and updating of SOPs
- For compliance with internal guidelines
- For the implementation of system improvements
- For the monitoring of the storage of retention samples
- Product assessments in course of release activities
- Comprehensive activities with other departments (Quality Control, Material Planning, Customer Service, Warehouse, Purchasing)
- Participation in audits
- Release Responsible (RER) for medical devices and cosmetic products
- Responsible person for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before the device is released (acc. To art. 15, 3.a Medical Device Regulation). In this function the responsible person is free from any instructions
- Natural science education (e.g. HTL, FH, University)
- At least 5 years of professional experience in administrative, GMP-related areas (regulatory, quality control or quality management systems)
- Sound knowledge in the creation of specifications for QM systems
- Experience with risk analysis and problem solving approaches (e.g. Six Sigma)
- Entrepreneurial thinking and action
- Extremely high degree of self-organization
- Efficient and respectful communication, high degree of social maturity
- Solution-oriented action
- Excellent German and English spoken and written
- Very good EDV user knowledge (MS Office)
- Leadership experience and SAP experience of great benefit
We offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you!
For this position, a salary of EUR 41,000, - (full-time) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.