SAP QA Deviation Controlling & Governance Specialist

Netherlands, Geleen
United States, Houston (Texas)

SAP QA Deviation Controlling & Governance

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

This position generates investigations, works with all departments (Quality Assurance, Manufacturing, Supply Chain, Quality Engineering and Quality Control) within the facility and may include data compilation and evaluation, impact assessments, root cause analyses, and corrective/preventive actions.

The Deviation investigator is responsible for the initiation, investigation of process deviations aimed at identification of root cause, and implementation of correct actions to prevent reoccurrence. The Investigator is seen as an investigational technical expert. The Investigator is expected to work in a cGMP environment, have the ability to manage multiple ongoing projects concurrently as well as mentor and train others within the group, have excellent meeting facilitation and conflict resolution skills, a professional and expert technical writing capability, action oriented, and be compliant minded while performing investigations.

Key responsibilities:

  • Ensure event and deviation timelines are maintained through inter-department communication
  • Able to handle more challenging, in-depth investigations utilizing more advanced investigational tools while still maintaining the high level of quality
  • Helps drive changes in processes/procedures. Able to assist the operational teams in submitting change controls, investigations, CAPAS, etc
  • Periodically summarize and present on-going process and performance metrics
  • Reporting to the Deviation Investigator Supervisor, Supply Chain Manager or Asset head directly in a professional manner at all times.
  • Perform other duties as assigned

Key requirements:

  • Bachelor or equivalent in Pharma, Supply Chain or relevant;
  • 5 – 10 years of experience in a similar position;
  • Experience with: Change Control, CAPA’s, Risk Assessment, FMEA
  • Experience with SAP, Trackwise (pre)

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R36991