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 an/a Contamination Control Strategy and Microbiology Expert.
- Implementation of contamination control strategy
- Responsible for leadership, management, and implementation of a Contamination Control Strategy (CCS) across the facility The strategy should consider all aspects of contamination control including: Facility/utility design, process design, personnel and material flow, cleaning and disinfection, environmental monitoring programm
- Implementation of preventive and corrective actions (change control initiator)
- Responsible for implementation of life cycle of this contamination control strategy with ongoing and periodic review
- Lead and/or support investigations related to microbiology or contamination control strategy
- Work closely with stakeholders in manufacturing, quality, validation to drive alignment to site contamination control goals and improvement initiatives
- Serve as the point of contact for inspection readiness with respect to contamination control
- Support microbial risk assessments for new products, equipments and processes
- A degree in Microbiology or other science (or non-degree with adequate work experience.)
- At least 5 years of related hands on experience in contamination control field in the pharmaceutical industry (preferably Quality or Manufacturing or related field)
- Strong analytical and problem solving skills
- Understanding of principles and methods for contamination control in clean room environments
- Working knowledge of microbial risk assessments HACCP/FMEA
- Knowledge of state-of-the art processes (industry standards, design rules) and systems related to production as well as contamination control and practices in cleanrooms
- Experienced to work in controlled/classified environments
- Understanding of Contamination/Cleanroom standards
- Experienced in leading projects including communicating plans and risks to management and stakeholders
- Excellent verbal and written communication skills in German and English
- Audit experience desired, preferably FDA audits
- Project management tools desired, six Sigma or other
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 56,000, - (full-time) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.