The Product Expert owns process knowledge throughout the commercial lifecycle, ensuring process capability through data trending and statistical analysis of critical variables
Job Summary
The Product Expert owns process knowledge throughout the commercial lifecycle, ensuring process capability through data trending and statistical analysis of critical variables.
Major accountabilities include maintaining oversight of the manufacturing process, creating product-specific Quality Risk Analyses, and ensuring inspection readiness for assigned products.
This role involves leading root cause investigations, initiating product improvement projects, and ensuring the continued state of validation for processes.
Matching Summary
The Product Expert owns process knowledge throughout the commercial lifecycle, ensuring process capability through data trending and statistical analysis of critical variables.
Skills & Requirements
Must-have
Process knowledge ownership
Data trending and statistical analysis
Quality Risk Analysis
Inspection readiness
Root cause investigation
Continued state of validation
Nice-to-have
Seamless knowledge flow
Cross-functional team involvement
Optimization project design
Continuous improvement mindset
Key Requirements
Degree in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical Engineering or equivalent
6-8 years experience in Process Support/Process Expert roles
Extensive GMP and analytical methods validation knowledge
Experience in data handling and applied statistics