- Create, distribute and track regulatory/compliance gap Analysis observations at the sites. Collaboration with Quality compliance teams is essential to ensure Gap Analysis observations and content is fostering increased compliance
- Responsible for the Regulatory intelligence process and tool (Redica) as assigned. The role ensures that information is used to its maximum potential: support to site inspection, gap assessment, trending of major Inspection observations…
- Responsible to manage global Quality Risk Management by coordinating frequent review of the site risk profile in regards to Quality Risks (CORP-28) as assigned. Analyse the data to define top quality and compliance risks that is communicated to management.
- Responsible that metrics are set and maintained globally to measure quality compliance and provide KPIs to BU Quality councils and Global Quality Council
- 3++ years experience in the pharmaceutical industry
- Studies in pharmacy, chemistry, biotechnology or similar
- Experience with GMP compliance and risk management