Indirizzo
Forma di lavoro Responsible for scale-up and transfer for cold products by developing and executing a validation strategy according to cGxP. Executing and managing new product introductions for clinical supplies and commercial supplies considering process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality.
Owns 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.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
• Ensure inspection readiness for all process related aspects of assigned products.
• Track and evaluate product performance, trending, detect issues, implementation of CAPAs.
• Support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
• Act as SPOC on site for technical transfer. Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Provide technical expertise for pre-validation / validation strategy.
• Initiate local change control in system on site and ensure approval and closure.
• Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
• Ensure timely availability of technical documentation according to Novartis guidelines.
