(Senior) QA Specialist Qualification (m/f/d)
Responsibilities
- Representative of QA Qualification in the project organization for new facilities or other projects in regard to qualification of facilities, utilities, equipment and systems
- Coordinating different QA interests during the project phase e.g. process, cleaning or other relevant QA objectives
- Driving implementation of new qualification strategy and being a strong decision maker when needed
- Compiling, reviewing and releasing Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports and more) as also supporting and approving quality risk analysis (e.g. FMEA)
- Performing assessments and approvals of technical change requests during the different phases of a project and lifecycle and their relevance to the qualification of facilities, equipment, utilities and systems
- Representing qualification topics during customer audits and regulatory inspections
- Being responsible to drive CAPA and Effectiveness Checks to completion and timely closing as well ensuring deviations are appropriately investigated and recorded in Deviation Reports
Profile
- Bachelor degree in Engineering, Chemistry, Biotechnology or a related field
- Significant experience in qualification within the pharmaceutical industry
- Good understanding of the applicable cGMP regulations would be an advantage
- General knowledge of engineering and manufacturing processes
- Ability to oversee project execution to identify non-compliance from quality standards
- Fluent language skills in German and English is required
Benefits
- A very renowned company
- You will work in an international environment
- Dynamic and innovative market environment
- Overtime compensation
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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