Quality Assurance Manager GMP/GDP (m/f/d)
Your responsibilities
- Provide Quality oversight of external GDP operations, e.g. lead QMS activities, including Complaints, Deviations, Change Control, Audits, Self-Inspections, and Training
- Ensure GxP partners (i.e. CMOs, Distributors, etc.) are compliant for regulatory inspections and monitor progress during inspections
- Support Batch Record review, release preparation and batch disposition of APIs, bulk drug product, and finished products manufactured by contract manufacturers
- Monitor performance metrics, provide regular updates to management on assigned project progress, and escalate challenges as needed
- Execute and support external and internal audits (GDP/GMP)
- Support Health Authority inspection and customer audits preparation and management
- Perform other tasks as assigned in accordance with SOPs, regulatory agencies, and GxP-Guidelines
Your profile
- Bachelor’s degree in science or a combination of education and equivalent work experience
- Pharmaceutical or biotechnology industry experience
- Experience in Quality Supplier Management
- Excellent knowledge in GMP and GDP regulations
- Worked in an area with commercial QA experience as an asset
- Experience with electronic Document Management Systems, Quality Management Systems, Serialization and Traceability Solutions
Your benefits
- Interesting working environment
- Support during the recruitment process by Hays
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.
Your contact at Hays
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