In this role, you will have the opportunity to:
61 Manage site validation master plan and its on-time execute by working with cross-functions.
61 Maintain site validation master plan and site validation list to cover all products and processes at site.
61 Guide local team to conduct and document validation activities to meet global requirements and customer expectations.
61 Provide validation training and share best practice with site functions.
61 Support validation work for product transfer projects.
61 Support commissioning & validation for new facility, equipment, instruments and tools.
61 Support process flow charts, process control plans and process FMEA activities.
61 Answer audit questions and customer inquiries on site validation.
The essential requirements of the job include:0202
61 Bachelor or Master in a scientific field, preferable in Life Sciences, e.g. bio, biomedical, chemistry, chemical, pharma, …02
61 Minimum five years of relevant experience in pharmaceutical, medical device or other regulated industry
61 Demonstrated ability to own and drive validation planning and execution.
61 Willing to collaborate with cross-functional team toward a common goal
It would be a plus if you also possess previous experience in:
61 Certified internal auditor for ISO 13485
61 Project management experience
61 Seek creative and/or innovative solutions to a known problem