Quality Assurance Expert (m/f/d)
Über uns
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.Ihre Aufgaben
- Approval of external service provider Quality Risk Assessments (QRAs) to enable identification and evaluation of various metrics, risks, trends, and potential quality and performance issues with the ESP in a proactive manner. Ensure communication and support mitigation of actions for potential risks
- Responsible for adequate QAAs / quality terms with ESPs are in place
- Responsible for approval / rejection of ESPs following qualification
- Responsible for approval of subcontractors of ESPs
- Responsible for review and approval of quality issues related to ESPs and ensure appropriate escalation of major and critical issues
- Collaboration with GDQ, VPG, GMA ERM, other applicable Vendor Business Offices and Procurement to ensure their involvement in the risk evaluation and timely communication to the business and follow-up on required actions
- Collaborate with VPG to review, tracking and trending issues related to ESP that are entered into the GDQ Risk Management Tool
- Review quality metrics, monitoring and reporting including follow-up with line functions and escalation
- Responsible for collection of KQIs from the QA databases globally and monitors them for all ESPs
- Ensure timely escalation of applicable vendor related issues with Head ESP QA and Vendor Alliance Head (or related function)
- Provides support for internal and external audits and health authority (HA) inspections pertaining ESP management. Ensure inspection readiness of ESP related activities
- Ensure compliance with regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility
- Ensure review and approve of audit request raised by assigned VPG partners to include in UQAP plan
- Provide support to the assigned projects/activities
Ihr Profil
- Minimum a bachelor’s degree in Life Sciences, Pharmacy or Medicine, or other related discipline required
- Profound English skills
- Extensive work experience in pharmaceutical development and excellent knowledge of the technical development and clinical operations processes and vendor related activities
- Profound knowledge of GCP/GLP, GMP, GVP
- Demonstrated leadership in implementing robust processes and quality systems, and setting global quality standards in a regulated area, including controlled documentation for the pharmaceutical development area
- Experience in managing ESPs and knowledge of quality standards requirements
- Thorough technical understanding of specifications setting, collecting, analyzing, and monitoring of Third-party service
- Experience in data analysis and trending using available tools
- Demonstrated effective management and establishment of successful international and cross-divisional collaborations
- Demonstrated root cause analysis skills, Stakeholder engagement and critical thinking
- Ability to work in a global team and matrix structure organization, meet timelines and work with minimal supervision
- Excellent communication and interpersonal skills
- Self-motivated with a high degree of ownership and responsibility for results
Wir bieten
- International Working Environment
Ihr Kontakt
Ansprechpartner
Linda Fritzenschaft
Referenznummer
727540/1
Kontakt aufnehmen
E-Mail: linda.fritzenschaft@hays.de
Anstellungsart
Anstellung bei der Hays Professional Solutions GmbH