Identify systemic gaps in quality/compliance by conducting internal audits of Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites
Prepare detailed audit reports to communicate observations
Maintain knowledge of GMPs and be aware of revised or emerging quality regulations
Promote positive Quality and leadership behaviors
Participate in ad-hoc quality compliance projects related to auditing
Requirements
Minimum of 10 years professional working experience in Pharmaceutical Industry
At least 5 years aggregate experience performing audits for GMP, ISO or ICH
Hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections
Must be an expert Quality compliance auditor
Experience with elements of data integrity covering all areas in a pharmaceutical manufacturing environment
Experience in sterile manufacturing and aseptic practice is desired
Professional auditor training/certification by an organization recognized within the pharmaceutical industry (e.g. IRCA, ASQ)
Strong foundation of pharmaceutical manufacturing and laboratory operations
Strong communication skills including listening, judgment, problem management, ability to lead teams in a sophisticated and global environment
Benefits
Health insurance
401(k) matching
Paid time off
Remote work options
Professional development opportunities
Applicant Tracking System Keywords
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