Merck KGaA Location:
A career at Merck is an ongoing journey of discovery: our 50,000 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.
Assign and monitor the workload distribution to ensure audits are completed in a timely manner based on contractual obligations and mail dates.
Identify regulatory compliance issues and interacts with other department to ensure compliance with internal procedures and GXP regulations
Reviews quality records/documents and conducts inspections, as need to support workload, for compliance requirements including highly custom and complex studies / productions.
Attends and/or leads cross-functional meetings / project teams as QA representative.
Ensure appropriate cross-training and professional development of staff occurs. Provides feedback, completes written performance reviews, documents any performances problems and takes appropriate action.
Trains and mentors other QA personnel in areas of expertise.
Supports client and regulatory inspections and may have direct interaction with clients and/or regulators.
Provides compliance /regulatory guidance to Operations for study / production planning purposes.
Who you are:
B.S. degree in science or technical area
A minimum of five (5) years experience in Quality Assurance or related field within a GMP environment.
Experience with manufacturing and Biological testing
Experience leading a project team is preferred.
Proficient to advanced knowledge of FDA and MHRA regulations
Strong Oral, written communication and interpersonal skills required
Proven project team leadership skills.
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
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