Head of product development állások, munkák minőségbiztosítás kategóriában

Write, review and approve design and development documents, including design inputs, outputs, verification, validation, and design transfer activities...

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

In your new role, you will define and implement the global strategy for analytical development, supporting BI's pipeline from early research through candidate characterization and selection to drug product development and launch....