Technical Leadership and Mentorship
You will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment, such as HPLC/UPLC, TOC analyzers, FTIR, microscopes, within the Industrial Operations and Product Supply of biological products. This must be in accordance with cGxP, regulatory requirements, and industry trends.
Your Typical Day
* Supervise the end-to-end qualification process to ensure each piece of equipment is suitable for its intended use, contributing to the 365 inspection readiness program.
* Implement a quality culture and follow company manufacturing standards, policies, and procedures.
* Schedule, execute, review, and approve qualification activities.
* Assess executed change controls and deviations for impact on the qualified state.
* Investigate and troubleshoot problems, determining solutions or recommendations for changes and improvements.
* Review, edit, and approve deviation notifications, investigations, and corrective actions.
* Collaborate with other departments and contractors/vendors to complete validation tasks.
Requirements
* Expert knowledge of EU Annex 11 and FDA 21 CFR Part 11.
* Strong knowledge of Data Integrity.
* Ability to prioritize and handle multiple tasks simultaneously.
* Project management experience.
Qualifications
* Bachelor's degree in Engineering, Chemistry, or Life Sciences.
* 8+ years of related experience within the field (may substitute relevant experience for education).