QA Configuration (Site)

Job Summary

Act as business partner to the site/entity manufacturing process managers and leadership in assuring and improving the manufacturing processes and product/service quality performance.

To provide Internal (1st Party) audit capability for the assessment of the manufacturing processes and products/services, ensuring process compliance, robustness and effectiveness in relation to the Customer requirements, quality needs and expectations. To plan, host and support external (customer, regulatory and other 3rd parties) audits.

To report & ensure conclusion on non-compliances, as well as highlighting improvement & best practice sharing opportunities and help drive a value added, continual improvement culture through the organization.

Job Responsibilities

• Ensuring the delivery of the manufacturing process/product audit objectives (when acting as the Lead Auditor), ensuring adequate preparation for the conduct of the audit criteria against the local audit plan;
• Within the specific audit criteria for gathering of appropriate audit evidence, recommendations and thus preparing the audit and distributing the audit report and conducting the audit follow up;
• For the evaluation of the audit evidence, non-conformities recommendations / opportunities for improvement and for the communication of subsequent recommendations, including risk identification to the BMS/QMS Manager;
• Provide planning and hosting of external 2nd and 3rd party audits including support to follow up activity support (e.g RCCA/NCR/OASIS) integrity management.

Job Qualifications