Introduzione

I vostri compiti

• Collaborate with local quality departments to ensure GMP readiness of new and legacy API facilities include pre-licensing preparation, efficient startup and product lifecycle management.
• Collaborate with cross-functional teams to ensure quality operations compliance with local and global quality regulations during the development, manufacturing, and release of APIs.
• Conduct KPI surveillance and internal audits to elevate particular areas of risk or concern for APIs production and enforce remediation action to support inspection readiness and increase API process robustness. 
• Act as a Subject of Matter Expert for GxP compliance of API quality operations & analysis and drive for further digitalization.
• Support the local quality organization in executing the Quality Culture Program and adopting Quality behaviors. 
• Master the complexity of the API manufacturing processes within the group and understand the potential sources of variability using the digital GxP systems. 
• Collaborate in Quality ad-hoc boards in case of API related Escalations to Management, immediately after being notified by a site, to ensure and support timely actions, effective communication, thorough investigation and effective CAPAs.
• Provide expertise in the implementation and optimization of global quality systems across API 
• manufacturing sites.
• Provide training and expertise to global teams on quality requirements, GMP practices, and industry regulations.
• Lead and support the global harmonization of local quality management systems, ensuring they meet regulatory and internal requirements for API manufacturing.
• Promote the principles of process design and the development of a comprehensive control strategy for manufacturing APIs of consistent quality by ensuring a practical application of quality-by-design (QbD), identification and mitigation of risks and process characterization. 
• In collaboration with the Operational Excellence department, foster a culture of quality excellence by driving continuous improvement initiatives and best practice sharing across the global network.

Il tuo profilo

•    University degree in Chemistry, Pharmacy, Biology, Engineering or other technical/natural scientific area.
•    Minimum of 5-8 years of work experience in manufacturing, quality control, quality assurance or other relevant area, in an API producing pharmaceutical/ CDMO company 
•    Profound knowledge of EU GMP and FDA regulations.
•    Experience with electronic Lab, Quality and Documentation Management Systems 
•    Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment.
•    High carefulness and accuracy in the way of working, conscientiousness and detail-orientation, strong ability to systematically gather and analyze data.
•    Strong interpersonal and communication skills, capable of influencing and collaborating with cross-functional teams globally.
•    Fluent in English. French, Italian or German are an asset.
•    Available to international travels up to 20%.