RLT Analytical Product Project Leader (m/f/d)
Job ID: REQ-10015150
Jul 11, 2024
Location: Ivrea, Italy
Summary
Role Purpose: Define, lead and manage the analytical project strategy including the overall analytical control strategy for Drug...
Contribution on preparation of the annual IS risk and control self
• assessment (RSCA) as well as other ad hoc assessment &, reviews.
• Work with the Regional and Global PB BRM to achieve a robust First Line of Defence in the Area
• Report on the internal...
efficiency and flexibility required by the RLT Pilot Plant nature.
About the Role
Key responsibilities:
• Prepare monthly engineering reports with key KPIs (Capex, Maintenance, HSE and Quality)
• Support internal and external audits
• Implement technical...
formulation and process-design, control strategy, quality risk management, authoring of development documents and manufacturing instructions for technical and GMP manufacture incl. handling of deviation.
About the Role
Role Responsibilities:
• Lead the...
RLT in contract discussions for effective collaboration with procurement, QA and other internal stakeholders.
• Accountable for monitoring and control of CDMO performance to identify any gaps or risks, and take appropriate action to address them...
upgrades, IT validation) as per responsibility.
• Ensure compliance with internal/external quality and safety guidelines (e.g., GMP, SOPs, Quality Manual).
• Drive continuous quality improvements for manufacturing, collaborating with production...