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Lead analytical equipment qualification for new equipment and technology introduction. Ensure timely implementation of projects with full compliance to corporate, regulatory, and external agency regulations. Collaborate closely with local and global stakeholders on new equipment and technology introduction and qualification. Write change controls, events/deviations, CAPAs, and GMP documents (e.g., SOPs, protocols, reports).
Job Responsibility:
Lead analytical equipment qualification for new equipment and technology introduction
Ensure timely implementation of projects with full compliance to corporate, regulatory, and external agency regulations
Collaborate closely with local and global stakeholders on new equipment and technology introduction and qualification
Experience in analytical equipment qualification, including computer system validation for analytical equipment
Knowledge of the operation of analytical equipment
Experience in QC testing
Knowledge of cGLP and cGMP
Knowledge of compendia and regulatory requirements
Academic background: University degree in a relevant science discipline with at least 2 years of relevant working experience, or diploma with at least 3 years of relevant working experience
Fluent English
You demonstrate strong project management and communication skills
Nice to have:
Other languages are a plus
What we offer:
Global Diversity: Be part of an international team of 110+ nationalities
Trust and Growth: 70% of our leaders starting at entry-level
Continuous Learning: internal Academy and over 250 training modules
Vibrant Culture: afterworks, networking events
Meaningful Impact: CSR initiatives, including the WeCare Together program