Responsibilities
- Accountable for local CSV and Quality deliverables defined for the local Deployment
- Definition of local Change Request/Validation/Implementation plans (incl. CSV) and related closure/reports
- Accountable for the local implementation plan, local implementation interim report, local implementation report according to CSV requirements and the respective SOPs
- Coordinate and support adoption of local SOPs (i.e. definition of the SOP inventory, planning of SOP updates and coordination of SOP updates according to plan)
- Supporting the training activities as well as test planning, execution, closure and defects
- Supporting data migration, esp., local verification and incidents associated with GxP data
- Supporting local cutover activities to ensure all protocols are completed and deviations accepted
- Supporting any definition of interim ways of working required during cutover
- Defining and supporting any PQ activities if required
- Compliance support for defects, incidents and change controls
- Coaching and training of local project team as required in related compliance approaches/deliverables
- Accountability for compliance, quality assurance, deliverable acceptance, and sign-off processes within the project
Profile
- Master Degree: A successfully completed engineering degree in the field of biotechnology, process engineering, mechanical engineering, electrical engineering or automation technology
- Manufacturing/GxP validation responsibilities
- Profound experience in quality management in the technical and CSV, qualification fields
- Extensive experience in the regulatory requirements in the GMP environment
- Knowledge of compliance work within a project/change environment
- Understanding of ERP life cycle, deliverables and the compliance needs/implications
- Previous deployment of global application to site highly advantageous
- Very Good x-functional understanding of compliance within a manufacturing site
- Ability to work in a matrix environment
- Experience in controlling/developing compliance deliverables and supporting other streams as appropriate
- Ability to work within a multicultural environment
- Fluency in English and German (written/spoken)
Benefits
- Interesting and responsible tasks in a multinational environment
- Remote work possible
- Long project duration planned
About Hays
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.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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