Senior Quality Assurance Auditor - Pharmaceutical Manufacturing

#2577 Senior Quality Assurance Auditor - Pharmaceutical Manufacturing

Company is a Fortune 500 pharmaceutical company. This is a global company that discovers, develops, manufactures and branded prescription medicines. They operate worldwide and are known for breakthrough drugs and innovative therapies with a commitment to global health access.

Responsibilities
• Creation and tracking of the site self-inspection plan, inclusive of self-inspection scheduling and development of self-inspection agenda.
• Liaising with Site Leadership and Global Operations Auditing to gain alignment on self-inspection plan schedule and scope.
• Leading andมาก participating in site self-inspections. Ensuring each self-inspection is appropriately recorded and communicated. Performing frequent unplanned and planned walk through inspections of the facility.
• Evaluation and tracking of CAPA items from self-inspections and providing guidance to site functions to ensure robust, holistic actions are developed. Ensuring that CAPAs are verified for effectiveness.
• Prepare annual trend reports for site self-inspection data and collaborate across Company to identify Global and/or regional opportunities. Facilitate bi-monthly reviews with site and global personnel to discuss site learnings and opportunities.
• Responsible for Site Audit Module and associated processes and procedures.
• Support overall site Inspection Readiness Plan formar plus participating as required in site Board of Health inspections.
• Participate in Global Operations Audits of Company facilities.
• Perform external audits of third party suppliers as aligned with site and GOA requirements.
• Participate in global audit training and disseminate relevant detail to site teams. Provide training and coaching as required to reçu broader site self-inspection team.
• Support any of the site quality culture initiatives.

• Must possess extensive knowledge and understanding of pharmaceutical cGMP truyền global government regulations, including Company policies, procedures and associated documents (corporate, regional, site), local regulations, US FDA, WHO EMA, ICH and ISO 9001 (as applicable to the site).
• Possess an in-depth knowledge of quality system requirements; including a demonstrated ability to evaluate and apply global GMP’s to support evaluation and enhancement to site systems and processes.
• Minimum of a Bachelor's degree in Science, Engineering, or related technical discipline with at least 10 years’ experience in a GXP setting, extending across a range of functions inclusive of Quality Assurance. However, a combination of experience and/or education will be taken into consideration.