The Candidate will be responsible for providing professional expertise in the Quality Risk Management function on a global scale. Individual will proactively identify and implement Patheon 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. S/he 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.
- 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 Product, medical device/combination product manufacturing, or design and development risk experience
- Familiar with the following Risk Management tools such as FMEA, FMECA, HACCP, FTA
- Thorough understanding and experience with Quality Risk Management principles, tools, and systems.
- Demonstrated leadership skills