Job Summary
As a Principal QA Validation Specialist, you will provide technical leadership and mentorship for qualification activities and data integrity initiatives in the Industrial Operations and Product Supply of biological products. You will be responsible for ensuring compliance with cGxP, regulatory requirements, and industry trends.
Main Responsibilities
* Provide technical expertise on equipment used for QC analysis and operations.
* Supervise the end-to-end qualification process to ensure each piece of equipment is fit for intended use.
* Foster a quality culture and implement company manufacturing standards, policies, and procedures.
* Manage site change control, risk management, and data integrity initiatives/programs.
* Participate in internal and external regulatory audits.
Key Requirements
* Strong knowledge of EU annex 11 and FDA 21 CFR Part 11.
* Expertise in Data Integrity.
* Ability to prioritize and handle multiple tasks simultaneously.
* Project management experience.
Qualifications
Bachelor's degree in Engineering, Chemistry, or Life Sciences. Minimum 8+ years of related experience within the field preferred.