Aug 13, 2021
-Technical Transfer LeadResponsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations.Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.).Product StewardOwns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving.Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support.Technical StewardProvides to the Site the specialist knowledge and expertise, as Subject Matter Expert (SME), of specific pharmaceutical processes or process technologies (e.g. Technical Steward for galenics, for film coating, biologics – upstream or downstream, etc.).Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.Validation LeadResponsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.Senior Scientist MS&TDesign, plan, perform, interpret and report scientific experiments under the lead of the department head to contribute to overall MS&T strategies and objectives.
Operations Management and Execution Project Management Collaborating across boundaries Fix-its/Turnarounds English Process and Cleaning Validation Manufacturing Process/Product Expertise Knowledge of CAPA Quality Change Control