01 ago - Italia
Chiesi Farmaceutici
Corporate Quality Auditing Sr Specialist Si assicuri di inviare la sua candidatura con tutte le informazioni richieste, come indicato nella panoramica del lavoro riportata di seguito. Department: Corporate Quality Operations Business Area: Quality Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT This is what you will do We are looking for an experienced GMP Auditor with a strong track record in supplier and external partner audits within the pharmaceutical industry. This role is primarily focused on planning and performing international audits of GxP suppliers and contractors, ensuring full compliance with GMP, GDP and ISO standards: Carrying out GMP/ISO audits of GMD contractors in full autonomy Drafting quality agreements Ensuring supplier qualification and validation according to GxP requirements and Chiesi quality standards Ensuring the quality of global suppliers and monitoring their quality performance. You will be responsible for Within the scope of Good Manufacturing Practices (GMP), Good distribution practices (GDP) and ISO 9001:2015 standards:
- Collaborating in internal/external audit activities at every stage: Perform on-site audits across Europe and worldwide Prepare audit agendas, lead audit execution, and write reports in English Collaborates in the issuing of annual audit plans (internal/external) Preparation (material collection, procedures, other official documentation) Contacts to be made with the supplier to be inspected Check proposed corrective actions Keeps the progress of audits updated, monitoring the progress and closure of corrective action Verification of the effectiveness of corrective actions Draws up synoptic tables on the general situation of the Audits (useful activity also for management review) - Participating in the drafting of the main sector operating procedures, defining their structure, requirements, etc. Keeps up-to-date the procedures related to GxP suppliers and service providers qualification, validat
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