Quality Systems Manager

Join us

At Gedeon Richter Debrecen site we're looking for our new team member as a Quality Systems 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:
Designs, implements and develops the Quality System Processes’ under it’s responsibility and ensures its compliance with applicable regulations and applicable Headquarter level Quality documents

Local owner of the following quality systems:
Deviation, CAPA and Change Control:

• Ensure the proper management and the development of the systems,
• Follow-up the related KPIs
• Hold regular trainings

Annual quality review:

• Prepare and participate in the annual product quality review and monitor action plans

Training:

• Follow up the quality training system and the process

Audits, inspections:

• Prepare the annual audit schedule and follow up its realization
• Conduct periodic reviews
• Prepare and participate in audits
• Follow-up the related actions and the audit system KPIs

Documentation system:

• Management of the documentation system
• Monitor the update and the lifecycle of the documents
• Support the users in the process flow

KPI:

• Coordinate the collection of quality KPIs and prepare periodic reports

Computerized systems:

• Maintain the inventory of computerized systems with their respective GxP criticality
• Carry out periodic access reviews on GxP systems
• Ensure maintenance of the process and related documents (improvement, updates)

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, assurance, and systems management
• Good understanding of pharmaceutical regulations, cGMP, computerized systems, including the MS Office suite

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