Responsible for execution and review support of Quality Assurance activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements.
Handling of Contract Service Provider. Facilitate for timely preparation, review and adequate response to the Observation and monitor CAPA planner for it timely closures.
Comply with internal and external timelines for managing adverse events and product complaint case processing, and case submission processes as appropriate.
Supporting Clinical Scientist for global studies. May serve as Study Leader and/or Clinical Scientist for low complexity global studies or local studies.