Quality Assurance Architect (m/f/d)
Responsibilities
- Supports creation and implementation of the aseptic operator training program
- Creation and update of procedures and risk assessments
- Ensureses adherence to global procedures and standards
- Creation of SOPs in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
- Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
- Supports Annex 1 Gap mitigation and remediation in collaboration with the manufacturing department (e.g. creation of work instructions, risk assessments, process design)
Profile
- Degree in Life Sciences e.g. Biology, Chemistry or Pharmacy
- Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance
- Well-founded experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing
- Extensive professional experience in aseptic process validation (Media Fill validation), aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning
- Demonstrated experience in quality assurance and regulatory compliance with EU GP Annex
- Business level language skills in German and English
Benefits
- A highly motivated team and an open way of communication
- A very renowned company
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
+41 44 225 50 00© Copyright Hays plc, . The HAYS word, the H devices, 'Hays Working for your tomorrow' and 'Powering the world of work' and associated logos and artwork are trademarks of Hays PLC. The H devices are original designs protected by registration in many countries. All rights are reserved.