Product Expert

Job Description Summary

The Product Expert (or 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.                       

• 6-8 years of experience in Process Support/Process Expert roles within the MS&T department of a pharmaceutical company.

• Extensive knowledge of GMP and analytical methods validation.

• Experience of data handling and applied statistics.

• Fluent in English and Italian.

 

Skills Desired

Applied Statistics, Assembly Language (ASM), Change Controls, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge  , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Processes, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Methods, Six Sigma, Statistical Analysis, Technology Transfer