Band
Level 3
Job Description Summary
The Product Steward 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.
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.
Job Description
Major Accountabilities:
- 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.
- Create and maintain a product specific Quality Risk Analysis (QRAs).
- 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
- Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
- Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.).
- Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.
- Design and manage optimization projects.
Essential requirements:
- Degree in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical Engineering or equivalent scientific degree.
- Solid experience in process support, Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC/MS&T.;
- Experience of data handling and applied statistics.
- Fluent in English and Italian.
Skills Desired
Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation, Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure)