Quality Manager (f/m) in the field of CAPA/NC - Tuttlingen (GOE-104601)

Tuttlingen  ‐ Vor Ort
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Beschreibung

Task:
• Review site CAPAs, NCs, IA Observations, Site Complaint Manufacturing Investigations, QPR and QSMR documentation
• Provide guidance on requirements
• Assist with the development and documentation of problem statements, bounding, containment, risk assessments, investigation, and action plan determination (corrections, corrective actions, preventive actions, and effectiveness monitoring)
• Ensure effective completion of activities
• Ensure timely escalation of product quality and compliance issues to the proper source (NC, CAPA, Product Quality Escalation)
• Execute CAPAs, NCs, and IA Observations related to site-specific QS
• Develops competency of resources at the site that execute CAPA, NC, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR by providing training and guidance on the execution and documentation of these processes,
• Drives timely and compliant execution of site NCs, CAPAs, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR by driving cross-collaboration across functions, monitoring progress, and elevating issues in a timely manner for resolution,
• Supports on site the timely collection, escalation and reporting of Quality System metrics to management. This includes:
• Provide management tracking reports for NC, CAPA, IA Observation, and Site Manufacturing Complaint Investigations
• Submit NC, CAPA, IA Observation, and Site Manufacturing Complaint Investigation metrics for QPR and QSMR
Performs administrative activities for NCs, CAPAs, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR. This includes:
• Coordinate activities related to CAPA Review Board (CRB) and facilitate forums for review of progress of NCs, IA Observations and Site Complaint Manufacturing Investigations (i.e. agenda, scheduling, documentation of minutes, tracking of activities)
• Support on-site QPR and QSMR, including coordination, preparation, execution, and tracking of activities,
• Support Product Quality Escalations for nonconformances or issues originating at the site, including the initiation, escalation,
coordination, tracking, and closure of activities
• Support the initiation of CAPAs
• Serve as site administrator for EtQ and Cognos

Requirements (Must have):
• Experience in working in a manufacturing / operations environment is preferred Knowledge of ISO and QSR regulations is required
• Experience in Quality Auditing and notified body inspections is preferred
• Experience with root cause investigation, change management, risk management and technical writing is required
• Experience in Quality Systems process development, support, integration or enhancement is preferred
• Fluent in English

Environment/Miscellaneous:
• full-time/onsite

Beginn: 01.09.2018
Dauer: 30.11.2018
Branche: Medizin/Healthcare
Start
09.2018
Dauer
3 Monate
Von
Allgeier Experts Consulting GmbH
Eingestellt
02.08.2018
Ansprechpartner:
Tobias Trockel
Projekt-ID:
1608328
Vertragsart
Freiberuflich
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