Overview
Oitsversee the Quality Assurance functions focused on GLP audits and compliance of Preclinical and Bioanalytical groups, internal GLP/GCP testing, and overall GXP Quality System support. Conduct internal and external audits, manage QA GLP operation, review data and documentation and provide supervision to QA Specialists.
Responsibilities
- Manage QA GLP operations
- Oversee execution of quality systems to support GLP testing,
- Administer, review, follow-up and approve QS documentation
- Write, review and approve SOPs
- Trend and report QA GLP quality system related information
- Perform data review and approval of method and equipment validation
- Prepare routine updates and project status report of GLP QA activities
- Provide QA assistance for GLP supporting GLP testing
- GLP SOP, protocol and report review and approval
- Perform Internal and external audits
- Supervise QA Specialists
Qualifications
- Strong knowledge of GLP quality systems, policies and regulations.
- Strong supervisory skills
- Previous GXP audit experience.
- BA/BS in Life Sciences.
- Minimum of 4-6 years GLP experience and GCP experience a plus.
- Minimum of 2 years supervisory experience
