Summary:
Contractor in this role will provide hands on support for vendor management systems, including completing vendor risk assessments, creating vendor management SOPs, reviewing and approving vendor surveys and remote audits. The individual will report findings in a clear, precise and factual way. In this role the contractor is expected to provide expertise and suggesting and evaluating changes to the vendor management system.
ROLE RESPONSIBILITIES:
• Write clear, concise SOPs on vendor management
• Review and approve vendor surveys
• Review vendor master files and ensure that documents are sufficient for vendor qualifications and oversight
• Develop vendor management tools and templates for implementation at the site
• Write risk assessments for vendors
• Aid implementation of vendor oversight activities
• Write and review vendor audit reports
• Approve vendor audit reports and questionnaires
• Compile and analyze metrics and vendor KPIs.
• Perform desktop and onsite audits (this is will be minimal)
Qualifications:
• Minimum 10 years of experience in a pharmaceutical, medical and/or combination product production environment.
• Experienced in auditing with GMP regulated industries required.
• Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.) required.
• ASQ Certified Quality Auditor is preferred.
• Experienced in vendor oversight and risk assessments preferred.
• Excellent written and verbal communication skills
• Expert skills in document manipulation and electronic document maintenance (e.g. Word, Excel, PowerPoint, SharePoint, Adobe Acrobat) and other data management tools.