DirecciónWork location : La Almunia de Doña Godina (Zaragoza).
We are a Novartis Company focused on transforming patients’ lives by leading innovation in nuclear medicine.
The Process Expert will provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards.
Key responsibilities :
- Collaborate with the line manager and other Production staff on several tasks (e.g. management of new processes, Deviation investigations, CAPA implementation for the production areas and processes, equipment validations and qualifications, New Building and equipment)
- Lead product and process related investigations and deviations, coordinating with other stakeholders to ensure that the production deviations are closed on time.
- For the area of competence supports the line manager for the implementation and sustainability of requirements related to Quality, Drug Safety and HSE within production
- Support technological and organizational interventions aimed at the improvement of manufacturing processes in terms of quality, productivity and costs and the optimization of the resources relating to the site, ensuring that all process changes in assigned products are managed through appropriate change control procedure.
- Support the continuous improvement of production activities from a GMP, HSE and efficiency point of view. This includes the execution of process validations, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution.
- Support with Developing production documentation (e.g. batch record, specifications, sampling and control methods, procedures, protocols).
- Act as Subject Matter Expert (SME) for the product and process knowledge, be knowledgeable of product and process trends by providing input to APQR for analysis and for driving process technology innovations
Hace 4 horas
