Beschreibung
Validation Expert (m/f/d)
Reference: -en
Start: asap
Duration: 10 MM++
Main tasks:
- Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools. Works collaboratively and cross functionally to help ensure that process risks are analysed, appropriately controlled and appropriately documented.
- Ensures that all validation activities are compliant current requirements and cGMP. Manages deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurance. Provides technical expertise and recommendations for validation of major or complex changes in manufacturing.
- Authors and reviews process validation protocols (e.g. launches, weak point remediation) and related reports. Reviews MBRs and associated change controls. Supports the execution at the shop floor.
- Responsible to translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
- Participates in pre-validation activites to ensure the success of commercial process validation.
Main qualifications
- BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology
- Fluent in English and German
- Experience in manufacturing/ manufacturing science and technology/technical development/quality
- Thorough understanding of Biotech (mammalian cell based) manufacturing processes and related process equipment
- Expert in reviewing and writing technical reports
- Experience in biotech process validation or biotech cleaning validation (plan and Report writing)
- Fundamental understanding of standard pharmaceutical analytical testing
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, 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 professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Zlatan Mujagic
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