Planet Pharma
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https://www.propharmagroup.com
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As a small life science company in the greater Boston area preparing for commercialization, seeks to add an inspection compliance consultant to their team for the next six months. In this role you will be responsible for helping to maintain quality, compliance, and operational efficiency. This role will coordinate inspection readiness activities, manage mock inspections, and oversee responses to inspection observations. It will also support internal and external audit schedules, consolidating quality efforts across various GxP disciplines and relieving individual functional areas.
Responsibilities:
• 8-10 years of relevant industry experience with master control, supplier quality management, quality agreements, vendor oversight plans, and both internal and external audits
• Oversee and maintain contracts and personnel files for external auditors
• Create and maintain a master audit schedule (internal and external)
• Maintain an approved supplier list and communicate status updates
• Coordinate tasks related to supplier qualification, approval, and requalification
• Monitor supplier qualification processes
• Organize audit kick-off meetings with FAL and audit teams to discuss audit plans
• Schedule closing meetings with FAL and auditors to discuss findings
• Schedule audits based on the approved audit schedule and availability of auditors/auditees
• Monitor and report on the health of the audit program
• Initiate supplier quality management processes for software providers
• Interview and select external auditors for systems-related audits as applicable
• Review and approve final audit reports
• Distribute audit reports to stakeholders/system process owners
• Evaluate and document responses to audit findings
• Document actions within the audit file and issue closure notifications
• Create and file audit certificates in the QMS
Audit Management & Quality Systems Consultant
Posted: 11/25/2024
2024-11-25
2025-01-04
Employment Type:
Contract
Job Category: Quality and Compliance
Job Number: 616045
Is job remote?: Yes
Country: United States
Job Description
- Position Level: Senior Manager / Manager, reporting to the Director of Quality Systems
- Location: 100% Remote
- Start Date: January 1 (6-months to start, potential extension)
As a small life science company in the greater Boston area preparing for commercialization, seeks to add an inspection compliance consultant to their team for the next six months. In this role you will be responsible for helping to maintain quality, compliance, and operational efficiency. This role will coordinate inspection readiness activities, manage mock inspections, and oversee responses to inspection observations. It will also support internal and external audit schedules, consolidating quality efforts across various GxP disciplines and relieving individual functional areas.
Responsibilities:
• 8-10 years of relevant industry experience with master control, supplier quality management, quality agreements, vendor oversight plans, and both internal and external audits
• Oversee and maintain contracts and personnel files for external auditors
• Create and maintain a master audit schedule (internal and external)
• Maintain an approved supplier list and communicate status updates
• Coordinate tasks related to supplier qualification, approval, and requalification
• Monitor supplier qualification processes
• Organize audit kick-off meetings with FAL and audit teams to discuss audit plans
• Schedule closing meetings with FAL and auditors to discuss findings
• Schedule audits based on the approved audit schedule and availability of auditors/auditees
• Monitor and report on the health of the audit program
• Initiate supplier quality management processes for software providers
• Interview and select external auditors for systems-related audits as applicable
• Review and approve final audit reports
• Distribute audit reports to stakeholders/system process owners
• Evaluate and document responses to audit findings
• Document actions within the audit file and issue closure notifications
• Create and file audit certificates in the QMS
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