Beschreibung
Principle responsibilities:
*Support the Technical Owner in technical, quality and compliance risk assessment and development of mitigation strategies
*Collaborates with different functions in product improvement projects
*Monitors technical process and product performance
*Supports failure investigations (escalation of quality or compliance events)
*Executes or follows-up on execution of technical projects
*Understands the technical aspect of the life cycle strategy of products
*Applies the science based risk approach and regulatory intelligence
*Monitors technical process and product performance across internal and external manufacturing sites
*Deploys the platform standardization policy as appropriate
*Reviews technical product & process risk profile and criticality analysis
*Looks for technical improvement and innovation opportunities
*Co-ordinates with manufacturing sites and process engineering the implementation of new process technologies (where appropriate)
*Identifies and resolves issues, anticipating to potential future issues
*Performs technical risk assessments
*Draft technical documents such as technical transfer plan and reports and bring them to review and approval
Ability Requirements:
*Strong expertise with regard to parenteral pharmaceutical products, manufacturing processes & tech transfer of parenteral products Good knowledge of Q&C/regulatory requirements/GMP/EHS
*Ability to support the leader of cross functional/cross-region project team
*Minimum requirements: BS/BA with 5-7 years' experience, M.S. with 3-5 years' experience in pharmaceutical development or pharmaceutical manufacturing of parenteral products or related post graduate academic experience/education.