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Quality Assurance Lead Auditor
2 months ago
FUJIFILM Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Lead Auditor to join our team. As a key member of our Global Supplier Quality Management team, you will be responsible for managing and leading the Supplier auditors performing Supplier Audits regionally and internationally.
Key Responsibilities:- Lead the Supplier auditor team in performing audits, generating audit reports, and managing supplier CAPA to ensure required actions are completed within the required timeframe.
- Collaborate with site management to instill a 'Quality Culture' by coaching in applying GMP Principles.
- Support the organization in conducting internal audits and hosting audits/inspections.
- Manage Supplier notification mailbox to ensure active management and delegation within the supplier team.
- Develop metrics to provide visibility of audits due, planned audit dates, audits complete, audit reports process timelines, and overdue audits.
- Bachelor's Degree in the Life Sciences/Engineering field and 3 years auditing experience within the Pharmaceutical/Medical Device industry.
- Experience with Good Documentation Practices, cGMP/GLP regulations.
- ASQ Quality Auditor Certification or equivalent.
- Leadership experience.
- Knowledge and understanding of EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices.
FUJIFILM Diosynth Biotechnologies is an equal opportunity and affirmative action employer. We are committed to diversity and inclusion in the workplace.
