Roche Looking for Auditor de Cumplimiento Interno- Calidad at Ciudad de México, México Full Time

Your Mission:

Conducts internal production/process and manufacturing quality control GxP audits (regulatory and self inspections), coordinates the technical GMP training and risk assessments. Reports discrepancies. Prepares audit plans and understands the specific issues to be evaluated. Executes internal audits within established manufacturing and production controls to ensure compliance with in-house and external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma). Develops formal written reports to communicate audit results to management and regulatory compliance agencies, if applicable, and makes recommendations as appropriate. May facilitate work of external auditors during on-site visits. May conduct vendor evaluation audits to determine qualifications.

• Performs quality management support activities for suppliers and distributors according to policies corporate:
• Establishes the annual audit program for suppliers (direct materials and services) and distributors with

GxP impact

• Manages the list of approved suppliers and distributors
• Co-manages the vendor evaluation process with process and procurement owners

(by conducting audits, sending questionnaires, establishing performance metrics)

• Develops and manages jointly with process owners the establishment of technical agreements and their

update

• Conducts or coordinates vendor audits, and in conjunction with the process owner monitors the

action plans.

• Manages and executes self-inspection programs to areas with GxP scope
• Establishes the annual program of inspections based on risk analysis
• Coordinates, executes and conducts the self-inspection report
• Follows up the action plans of the audited areas
• Manages and coordinates attention to Corporate and Regulatory audits
• Engages with auditors, develops and manages the agenda
• Coordinates the requested documentation during the audit process
• Coordinates the development of the audit report response
• Monitors, submits, and closes CAPAs﴾ audit observations﴿ with the process owners to the audit team in compliance with the engagement date
• Manages GxP risks, facilitating and supporting the “process owner” in detection, evaluation, control and communication, using risk analysis tools according to corporate policies and local regulation
• Manages the process of implementing corporate quality policies ﴾PQS﴿ and updating, through communication of the changes and the follow up to implement them
• Manages and controls the training system by establishing and updating the training matrix, trainig program, establishing the traininf log system in the corporate tool and moniitoring compliance of the annual training plan

Key Requeriments & Experience:

• Experience and knowledge of in the pharma industry
• Bachelor degree in chemical engineers, graduates in biochemistry or related careers
• Internal Auditor Certification
• Advanced in English

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.