| About Our Global Quality Audit and Inspection Group Our Global Quality Audit & Inspection Group is a team oriented department with colleagues across the globe, with regions in the Americas, Europe and APAC and the Far East. You will have the opportunity to work with several Group colleagues during audits when we perform our Global Risk Assessment (GRA) audits of our internal Teva sites. Not only does the audit team identify observations and gaps at the site, you will also assist in remediation activities as members of cross functional teams. The team also supports internal Teva site with their inspection readiness program and periodically performs special assignment visits focusing on key gaps that require immediate remediation. Position Summary You will perform GMP/GDP audits of pharmaceutical manufacturing, packaging/ labeling, laboratory controls, technical services, storage & distribution and quality systems for sterile/non-sterile APIs, drug products, medical devices, combination products, packaging materials and services. GMP/GDP audits are normally take place in the Americas on behalf of Teva sites and business partners worldwide. They are scheduled, prepared, conducted and followed up by the auditor based on Teva’s annual audit work plan and agreed GMP standards. Audit scope includes external Vendor audits and internal Corporate Quality audits of Teva sites .You Will also insure Teva sites have robust inspection readiness plans in place to insure smooth regulatory agency inspections and successful product launches. Key Responsibilities - Scheduling, preparation, conducting, documenting and follow-up of assigned GMP/GDP audits in accordance with Teva corporate standards
- Initial assessment of audit deficiencies, corrective and preventive actions, and overall site compliance status based on regulatory GMP requirements and specific Teva requirements
- Provide support to Teva site with supplier qualification issues and supplier risk assessment based on audit result when required/requested
- Support notification to management process in case of critical audit findings in collaboration with audit hub manager and audit plan owner
- Regular participation in GMP trainings (internal/external)
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