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Requisition ID: 1805624592W
The NPI Manager is responsible for managing and coordinating the NPI activities of the One Lab associates engaged in transferring primary and secondary analytical method and technology transfers to ensure compliance with quality standards
Tasks and Responsibilities
Technical and job specific
• Ensure NPI projects are in line with the FPX transferring timelines, resources and budget.
• Manages implementation/transfer of test methods, new technologies, training and procedures.
• Ensure NPI team is subject matter expert and has a leading role during the GMP inspections.
• Review and authorize validation documentation related to the NPI test methods.
• Assess/Initiates Change controls related to the NPI projects.
• Participate in Management meetings; NPI One Lab network community and PDMS
• Mentors, coaches, trains and develops the quality control staff. Evaluates performance and provides opportunities for growth.
• Manager the budget of the group with regards to planning and allocations
Employee safety and health
• Ensure that procedures and guidelines linked to safety and health are met
• Ensure that the group complies with the environmental procedures and guideliness
• Ensure overall compliance to regulatory cGMP requirements, global standards, procedures, etc.
• Ensure that data are generated and maintained according to current regulatory requirements
Education / Qualification
- Master degree in chemistry & biotechnology or equivalent by experience with 8-10 years’ experience in the pharmaceutical industry.
- Experience in Quality Control, Method development, validation, etc.
- Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, JPN, etc.)
- General knowledge of pharmaceutical development & manufacturing
- Organizational planning and problem solving experience
- Strong leadership & development qualities
- Experience with principles of Process Excellence, Lean manufacturing, etc.
- Good presentation skills
- Excellent knowledge of English
Personal and interpersonal skills
- Analytical thinking
- Strong Quality Awareness
- Stress resistant
- Organizational and people management skills
- Dealing with intercultural differences
- Work independently
- Team player
- Open minded
- Open for change and improvement
- Accurate and analytical mindset
Janssen Biologics (7266)