KYOWA KIRIN INTERNATIONAL HOLDCO Salary
2 GLOBESIDE FIELDHOUSE LANE MARLOW SL7 1HZ UNITED KINGDOM
TIN: 14473663
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Earnings on positions in KYOWA KIRIN INTERNATIONAL HOLDCO
KYOWA KIRIN INTERNATIONAL HOLDCO is looking for employees for positions:
auditor
Trade
- management
- Management
Requirements
- bachelor’s degree required and in science/life sciences preferred
- strong experience in GCP/GLP auditing including detailed knowledge of EMA, FDA, MHRA, ICH regulations and other applicable regulatory requirements
- use of Veeva or similar QMS systems for electronic QA Management preferred
- demonstrable ability to organise, prioritise, meet deadlines, make decisions, and change course of action quickly
- strong interpersonal and communication skills
- passion for personal learning and development to be able to grow with the company
Responsibility
- prepares timely well-written reports, obtains/evaluates audit responses and oversees tracking mechanism for QA audits and manages CAPA as per KK standards
- provides ongoing feedback to management on potential quality-related risks
- supports process improvement initiatives and maintenance of SOPs and other controlled documents in the quality document management systems
- maintains high degree of knowledge of global industry expectations and GCP/GLP regulations to ensure high quality of audits performed
- participates in Health Authority inspection activities for domestic and international projects
- performs, reports assigned GCP/GLP audits of KK studies, including but not limited to clinical investigator sites, vendor/CROs, internal system/processes, clinical data and documents, as applicable
- develops and delivers GCP-related training to KK staff as needed
- provides input to the annual risk-based audit plan, schedule and execution of audits based on changing business environment and interaction with cross-functional teams