A career at Merck is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: Act as quality management representative in development projects for drug delivery systems for injectable drugs: Ensure design control compliance, lead the qualification and monitoring of suppliers, identify applicable quality and regulatory requirements, review and approve all project deliverables, review and approve training, promotional and labelling material, participate to design reviews. Participate to material consolidation for submission purpose. Participate to MDR transition. Support regulatory submissions worldwide
Act as quality management representative for the maintenance of marketed drug delivery systems: Ensure compliance of the deviation and complaint handling processes related to the device, lead the corrective and preventive action process related to the drug delivery systems, perform the quality/regulatory assessment of proposed changes related to the drug delivery systems, supervise the change control process related to the drug delivery systems, ensure continued compliance to new or revised regulations and standards
Maintain supplier qualification (periodic assessments, audits)
Support regulatory submissions/renewals worldwide
Participate to MDR transition
Who you are
What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2merck.com