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).
Liaise with Regional and Global Technical, as well as other site functions such as QA, QC, Engineering, and Operations to ensure that proper controls are established and maintained for products to be manufactured in a validated state of control.
Actively participates and define technical transfer activities for incoming products to the site for OSD formulations mainly tablets, capsules and powders (sachets).
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 performance
Process validation and control
Critical quality attributes (CQAs)
Critical process parameters (CPPs)
Data trending and statistical analysis
Technical risk assessments (TRA)
Nice-to-have
Agile, performance-focused culture
Deep human understanding and trusted science
Ability to inspire others to improve
Strong communication skills
Key Requirements
BS degree in Chemistry, Engineering, or related area
Minimum of 3 years experience
Experience implementing FDA and/or GMP regulations