A leading auditing firm seeks a Mid-Senior level GMDP/GCP Auditor to manage audits ensuring compliance with global regulatory standards. The ideal candidate will have over 3 years of auditing experience in pharmaceutical manufacturing and a deep understanding of GCP and GMDP regulations. Responsibilities include developing audit programs, managing audit resources, and maintaining supplier qualifications. Benefits include comprehensive medical and vision insurance, alongside a 401(k) plan.
Qualifications
3+ years auditing experience in a regulated environment.
Broad experience in pharmaceutical manufacturing and distribution.
Strong knowledge of EU GMP, GDP, and FDA regulations.
Responsibilities
Develop and execute GMDP and GCP audit programs.
Manage audit resources and maintain auditor list.
Conduct audits of manufacturing and distribution against GMDP/GCP requirements.
Perform due diligence for supplier qualification.
Develop and manage CAPA plans with auditees.
Skills
Auditing experience
Knowledge of GCP regulations
Regulatory compliance
Management of audit programs
Collaboration with cross-functional teams
Job description
A leading auditing firm seeks a Mid-Senior level GMDP/GCP Auditor to manage audits ensuring compliance with global regulatory standards. The ideal candidate will have over 3 years of auditing experience in pharmaceutical manufacturing and a deep understanding of GCP and GMDP regulations. Responsibilities include developing audit programs, managing audit resources, and maintaining supplier qualifications. Benefits include comprehensive medical and vision insurance, alongside a 401(k) plan.