Our client is a multinational pharmaceutical company that strives to discover and enhance life-changing medications for patients while impacting society with its innovative clinical developments in various therapeutic areas. They have high efforts in putting patients first.
Review regional and local SOPs versus global policies to provide feedback to the Clinical Research team
Escalate compliance issues to management locally and globally as necessary
Communicate and ensure inspection readiness requirements are in place
Assist in interpreting regulations and guidelines and act as a main contact for global affiliates
Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process
Monitor completion of deviations, CAPA related to deviations and change controls
Share key learning to drive simplification and replicate best practices in the region and globally
Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections)
The Successful Applicant
Study background: Bachelor\'s or Master\'s degree in Life Science, Pharmacy, or a related healthcare field
Three years\' experience in quality assurance/regulatory affairs/clinical operations/medical affairs
Proactive and effective interpersonal relationship & communication skills in English, both verbal and written
Demonstrated ability to implement quality systems and risk-based decisions within a regulated environment
What\'s on Offer
Advanced and innovative solutions to improve patient health
Performance-based meritocracy that rewards great individual
A work environment with a focus on your personal and career growth
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