Req ID: R0011462
Novex Pharma Limited is the leading global pharmaceuticals company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
He/She will responsible for the following main activities:
Execution of process investigation (CAPA, NCR, internal Complaint) and product impact assessments
Trouble shooting on the floor and problem solving
Provide technical support with regard to manufacturing processes
Support manufacturing by continuous process improvement and process stabilization initiatives (Yield, cycle time and compliance improvement projects, validation projects)
Evaluate/organize the evaluation of process trending data, identify relevant trends and plan and execute proactive process stabilization activities
Preparation of technical documents and process risk assessment
Evaluation/preparation of planned process changes within Change Control System
Support for internal and external audits
Participation to internal and/or external multifunctional/functional team
Securing that all internal and external requirements regarding GMP, EHS, and safety fulfilled
He/She will be in close contact with the site’s manufacturing/quality organizations and global stakeholders provided to the site’s operations.