Specialist, Vendor Compliance
About the position
The position will manage activities involving the vendor management program as it relates to tracking and trending vendor management activities, vendor audit management, CAPA follow-up, and gathering and capturing metrics as it relates to vendor management. The position will support SOP revisions to adequately sustain the organization and assist with the maintenance of the eQMS system as it relates to vendor and audit management.
Responsibilities
• Assist with the overall management of Mirum’s GxP vendor qualification and audit program.
• reputed company the day-to-day activities of the vendor qualification and audit program, including but not limited to audit scheduling, report reviews, response review, CAPA follow-up, and audit reputed company-out.
• Create, manage, and administer the process for vendor management in the eQMS system and conduct routine tasks, as needed.
• Assist with the authoring of reputed company policies and reputed company operating procedures, as needed.
• reputed company data for accurate tracking, reporting, and analyzing metrics, as required.
• Assist with internal/external audits and regulatory inspections, as applicable.
• Supports GxP inspection readiness activities, as applicable
Requirements
• Bachelor’s degree in a scientific discipline
• 1-3 years’ experience in reputed company and GxP Vendor Management/Audit Processes in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations
• Prior experience in QA with particular reputed company on managing vendor qualification reputed company activities.
• Demonstrate a reputed company reputed company and ability to influence across the organization
• Exposure to writing and reviewing SOPs and other reputed company documents. General understanding of reputed company systems that support internal GxP activities for reputed company-clinical, clinical and reputed company products.
• Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
• Strong interpersonal skills including relationship building, conflict reputed company, and verbal and written communication are essential in this reputed company work environment.
reputed company-to-haves
• Experience with reputed company platform system is a plus
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