Beschreibung
Quality Assurance Specialist (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Supports establishment of GxP Global Procedural Documents throughout all of the development related organizational enterprises to ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety/pharmacovigilance which meet internal and external standards of regulatory compliance, as well as industry best practices and interpretations
- Builds and maintains strong relationships with key business stakeholders and ensures that the department is providing an efficient, effective and compliant process landscape to the functions.• In close collaboration with supported functional areas and key business stakeholders, identifies needs for process standardization, regulatory compliance direction and areas for improvement
- Ensures that business partner expectations for Procedural Document strategy, materials and deployment are met
- Ensures, in collaboration with business partners, that Global Procedural Documents in the GxP process landscape are up-to-date and regulatory compliant versus current Clinical and safety/pharmacovigilance international regulations
- Collaborates with a network of subject matter experts (SMEs) across the functional areas, supporting the Global Procedural Documents development
- Contributes to the Standards, Systems & Processes Governance Team to set strategies and achieve the long-term goals and objectives
- Knowledgeable of all services and activities, Standards, Systems and Processes Governance in order to provide business stakeholders with a comprehensive overview and effectively
- Communicates this to stakeholders
- Support internal process improvement projects
Main qualifications
- Bachelor’s degree or equivalent in scientific or quality-related field
- Several years experience in pharmaceutical industry
- Previous experience working in a GCP/GVP Environment
- Working experience of SOP creation & writing
- Soft skills: stakeholder management (in a global matrix environment) & organizational skills
- Experience in preparation, development and administration of GxP standards and processes
- Organizational awareness (e.g., interrelationship of departments, business priorities), including experience successfully working cross-functionally and in global teams
Main advantages:
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical industry, 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 professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Emina Mustafic
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