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 Quality department and therefore looking for a/ an Quality Specialist for external manufacturing.
- Support interface function between Contract Manufacturers (CMOs) and CROMA internal departments
- Support establishing and maintaining strong relationships with CMOs and internal peers to develop and deliver shared objectives
- Provide operational expertise to support transfer of all relevant aspects of the product specification to the CMOs
- Contribute and ensure the qualitative requirements for product and production at the contract manufacturer are met
- Support development, maintenance and communication of suitable KPI dashboards to measure CMOs / CROMA performance ensuring business and patient supply and quality needs are achieved.
- Participate in the continuous monitoring of contract manufacturers on the basis of KPIs
- Support and ensure timely escalation of issues and risks as relevant to appropriate stakeholders
- Participation and analysis of CMOs in the context of the troubleshooting processes
- Support operational issues are effectively resolved and that supply risks are being proactively managed
- Contribute for corrective and preventive actions for the further development of the product and the process maturity
- Contribute for the complaint handling and relevant root cause investigation
- Contribute for the product,- process,- system audits
- Support business objectives and manufacturing, supply and quality deliverables are met by CMOs
- Support identification and implementation of continuous improvement initiatives within the External Manufacturing & Operations team
- Minimum of 5 years' experience in providing operational / technical support to medical devices, pharmaceuticals and combination products manufacturing
- Significant knowledge of manufacturing processes
- Comprehensive understanding of Medical devices, GMP requirements for commercial manufacturing
- Experience of developing operational KPI dashboards and interpreting the data to identify improvement opportunities
- Experience of working with CMOs and matrix teams would be a distinct advantage, demonstrating strong communication and influencing skills
- Ability to coordinate Quality oversight working with external site Quality.
- Ability to review Quality documents and data ensuring compliance to GMP. Documents to include batch records, analytical data, logs, and others.
- Ability to write Quality documents such as SOPs, protocols, and others to ensure compliance with process and GMPs.
- Ability to review and apply release requirements to product, process intermediates, raw materials and components for GMP use
- Fluent in English, Knowledge in Korean is an Advantage
- Minimum BS degree in a Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field. Advanced degree would be an advantage.
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 38,000, - (full-time) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.