Contamination Control Strategy Expert (m/w/d)

  • Stelleninserat
  • Arbeitgeber
Drucken

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.

Jetzt bewerben

Weitere Jobs, die dich interessieren könnten

Alle 40 Strategy Jobs in Niederösterreich anzeigen

Erhalte Strategy Jobs in Niederösterreich per E-Mail