Your tasks:
- Execution of work packages related to quality management, quality system, and quality compliance functions.
- Identification and assessment of potential weaknesses and risks of processes and systems
- Contact person for quality assurance matters in the project
- Technical support for quality assurance in the area of computer software validation and data integrity of new processes
- Coordination of implementation activities between all departments
- Participation in internal and external inspections as an expert within the oneLIMS project
- Coordination and monitoring of measures in accordance with the change control strategy
Your qualifications:
- Completed studies in natural sciences, engineering, pharmacy or comparable qualification
- Solid professional experience in the pharmaceutical industry within a GMP-regulated environment
- Solid practical experience in Computer System Validation (CSV) including the execution and documentation of validation projects.
- Excellent knowledge of the relevant GxP requirements, data integrity, and GAMP 5.
- Experience with LIMS or comparable GxP-relevant systems; knowledge of LES is an advantage.
- Deep understanding of QC laboratory processes, analytical methods and quality-relevant IT systems
- Experience in international and cross-functional projects, ideally in implementation, digitization or migration projects.
- Strong analytical skills as well as a structured, solution-oriented and independent work style.
- Strong communication skills, assertiveness, and enjoyment of collaborating with diverse stakeholders.
- Fluent German and very good English skills
About Hays:
With over 15 years of experience in the traditional pharmaceutical, biotechnology, chemical, and medical technology industries, we know the key contacts who advertise challenging positions with high potential. The strong demand for personnel opens up exciting opportunities for dedicated specialists and managers to develop professionally and advance their careers. As a specialized recruitment consultancy with an international network, we offer you significant advantages – completely free of charge. Register now and benefit from interesting and suitable positions and projects.
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