Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs)
Job Summary
Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs).
Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.
Lead or contributes to, as required, change controls impacting products or manufacturing processes.
Matching Summary
Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs).
Skills & Requirements
Must-have
Product knowledge and process expertise
Continued process verification (CPV)
Product control strategies (PCS)
Technical risk assessments (TRA)
Process validation execution
Manufacturing equipment technology knowledge
Nice-to-have
Agile, performance-focused culture
Human understanding and trusted science
Inspire others to improve
Proactively solving problems
Key Requirements
Minimum of 3 years experience
BS degree in Chemistry, Engineering, or related area
Experience implementing FDA and/or GMP regulations