Sterility Assurance Manager

Join us

At Gedeon Richter Debrecen site we're looking for our new team member as a Sterility Assurance Manager.

In this role the incumbent acts as the process owner for designated processes and acts as a leader of an energised and motivated team.

What you'll do

Main responsibilities:
Design, implement and develop the Sterility Assurance related processes under it’s responsibility and ensures it's compliance with applicable regulations and the Headquarter level Quality documents.

Local owner of the following systems:
Environmental monitoring, Utility monitoring, Cleaning and disinfection, Aseptic Process Simulation and Trending:

• Ensure the proper management and the development of the systems,
• Follow-up the KPIs
• Maintain the SOPs which are regulating the topics
• Act as local system owner and a subject matter expert of the environmental monitoring, utility monitoring and cleaning and disinfection program of the site
• Support the production units in Sterility Assurance topics 

Training:

• Hold regular trainings in the topic of aseptic processing/manufacturing and hygiene

Trending:

• Maintain and develop the related trending procedure
• Prepare periodic trend reports
• Perform the evaluation of the analyzed data

Audits, inspections:

• Conduct periodic reviews
• Prepare and participate in audits

What you'll bring

• Educational background as a pharmacist or engineer, and experience in quality management on a pharmaceutical site
• Fluid English both verbally and in writing
• Excellent communication skills and analytical, structured approach to problem-solving
• Proactive, collaborative, and carry a sense of responsibility
• Autonomy, reactivity, results oriented personality
• Several years of experience in the pharmaceutical industry, with a preference for quality roles such as quality control (microbiology) or Sterility Assurance
• Good understanding of pharmaceutical regulations, cGMP, aseptic manufacturing

We offer

You can work in a team of helpful colleagues, where we value supportive collaboration and thinking together. In addition, we offer
•    Challenging, responsible professional work
•    Opportunity for continuous development
•    Long-term employment in an innovative and secure workplace
•    Training and development opportunities
•    Medical services and life insurance
•    Various sport and health opportunities
•    Extensive benefits package