External Quality Specialist (m/w/d)

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.

 
Ihre Aufgaben
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

Ihr Profil
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.

Wir bieten
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.