- Reference: GY44936AO
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
Responsible for providing professional expertise and leadership in the Quality Risk Management function on a global scale. Individual will proactively identify and implement industry best practices for GMP Quality Risk Management, including but not limited to internal processes that support manufacturing, quality control, materials management, validation and quality assurance
- Develop and maintain quality risk management system supporting the function of Industrial Operations and Product Supply (IOPS) division at a global scale.
- Formulate risk management principles, methods and tools, and document in appropriate policies, procedures, and reports.
- Establish training requirements for IOPS staff in quality risk management principles and practices.
- Oversee timely facilitation and completion of risk activities
- Manage data analysis and statistical tools used to support quality risk management activities.
- Manage personnel in multiple IOPS sites
- Communicate the outcome from quality risk management activities and periodic IOPs-wide reviews.
- Ensure appropriate application of quality risk management in IOPS overall Quality System.
EDUCATION AND EXPERIENCE
• Requires BS/BA in scientific discipline or related field plus minimum 10 years of relevant experience. May consider significant industry experience in lieu of educational requirement.
• 10+ years of experience of pharmaceutical manufacturing, medical device/combination product manufacturing, or design and development risk experience
• Thorough understanding and experience with Quality Risk Management principles, tools, and systems.
• Demonstrated leadership skills
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com