Quality Risk Management Officer - Pharmaceutical Manufacturing
Thermo Fisher Scientific, Inc.
Monza, Italy
5 gg fa

Job Description

Monza site is a world class contract manufacturing and development facility, specialized in aseptic injectable drugs, with an increasing focus on biologics.

Acting as Quality Management Risk Officer, you will be responsible for providing professional expertise in the Quality Risk Management function on a global scale, implementing company’s guidelines and standards for GMP Quality Risk Management Process, including but not limited to quality of products, processes, facilities, utilities, equipment, analytical and test method.

You will join a dynamic, international and fast-growing environment, in which a proactive and result-driven approach will be rewarded with a fast professional and technical growth.

Essential Functions

  • Develop and maintain quality risk management system
  • Implement risk management principles, methods and tools, and document template according to Patheon Global Standard Procedures;
  • Establish and execute training requirements for site SME in quality risk management principles and practices.
  • Oversee timely facilitation and completion of risk activities
  • Coordinates the local team Risk Review Team
  • Manage data analysis and statistical tools used to support quality risk management activities.
  • Communicate the outcome from quality risk management activities and periodic reviews;
  • Manage, properly update and monitor the Risk Register and site Risk Plan
  • Conduct periodic risk review
  • Able to escalate and communicate issue
  • Experience and Required Skills :

  • Requires MsC / BsC in scientific discipline
  • 3-5 years of experience of Pharmaceutical Manufacturing, Biological, or Medical Device Production, or design and development risk experience.
  • Familiar with Risk Management tools such as FMEA, FMECA, HACCP, FTA
  • Deep understanding and experience of Quality Risk Management principles, tools, and systems as well as GMP principles
  • Demonstrated leadership and communication skills
  • Joining more than 950 colleagues on site, the selected candidate will experience a smart, international, and fast-growing environment.

    With revenues of more than $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

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