Major Accountabilities
- Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
- For the area of competence supports the line manager for the implementation and sustainability of all Legal, GMP and Novartis-internal requirements related to Quality, Drug Safety, P&O 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.
- Performs the necessary activities for the preparation and production of validation and/or commercial batches. Focuses and coordinates technicians on providing right first-time batch records and process documentation.
- Develop / review / revise 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
- Manufacturing Excellence– for the product(s) assigned
- Supports and interacts with the production supervisor in the execution and/or supervision of the entire batch process including batch record review, aseptic set up, preparation, production and final equipment decontamination.
- 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.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
Education: Scientific background
Languages: Good reading/writing/speaking of English
Experiences: Two years experience in an aseptic/radiopharmaceutical/GmP/Pharmaceutical manufacturing environment
Languages: Good reading/writing/speaking of English
Experiences: Two years experience in an aseptic/radiopharmaceutical/GmP/Pharmaceutical manufacturing environment
Division
Oncology
Business Unit
ADVANCED ACCELERATOR APPLICATIONS
Country
Italy
Work Location
Colleretto Giacosa
Company/Legal Entity
AAA Italy Srl.
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
