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QMS Auditor
Education and/or Special Training EDUCATION:
• Bachelor's Degree required.
• Internal or lead auditor certification (CQA/CQE) required.
Job Description JOB DESCRIPTION:
1. Performs internal quality assurance audits to 21CFR 820, ISO 9001:2000, ISO 13485:2003, 93/42/EEC and other applicable Standards to ensure corporate and regulatory compliance.
• 2. Ensures effective and timely audit closure of all nonconformities cited during audits. Create formal audit reports and assign corrective action-as appropriate.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Performs internal quality assurance audits to 21CFR 820, ISO 9001:2000, ISO 13485:2003, 93/42/EEC and other applicable Standards to ensure corporate and regulatory compliance.
• Perform external quality assurance audits on new and existing suppliers to ensure compliance to corporate requirements.
• Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformities cited during audits. Create formal audit reports and assign associated corrective actions.
• Develop/modify audit checklists as regulatory requirements change.
• Present internal audits findings quarterly at management review meetings.
• Develop and conduct effective training programs on related QA topics.
• Conduct and support benchmarking activities.
• Identify areas of opportunity and support continual improvement of the Quality Management System.
• Identify, develop, and report QMS metrics.
• Participation in continuous (breakthrough) improvement activity and process re-engineering projects in support of Business Process Excellence initiative.
Qualifications/Work Experience QUALIFICATIONS:
• Self-motivated with the ability to effectively work with others in various coordinate disciplines, on multi-national teams, and to prioritize tasks in a deadline-driven environment.
Percent Travel Required 5%
contact
Jamie@pharmasearchpartners.com
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Position Type:
Employee
Ref Code: jr005 |
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