Contamination Control Strategy Expert (m/w/d)

  • Stelleninserat
  • Arbeitgeber

Contamination Control Strategy Expert (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 an/a Contamination Control Strategy and Microbiology Expert.

Ihre Aufgaben

  • 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

Ihr Profil

  • 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

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 56,000, - (full-time) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.

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