CMC Specialist 100% (m/f/d)
Your responsibilities
- Change assessments for multisite biologic products including clarification with SMEs
- Assessing changes and supporting submission with CMOs
- Revision of technical documentation
- Managing operational activities for the variation submissions e.g uploads of documents, maintaining trackers, QC of submission packages
- Compliance check of 32A1 part of the dossiers
- Maintaining information in submission tracking systems
Your profile
- Knowledge about Establishment and process for Change Control
- Knowledge about international Guidelines for Post-Approval CMC Changes
- CMC Dossier structure for biologics
- Authoring and managing review process of biological dossiers
- Experience in Qualification, Cleaning and Validation will be beneficial
- Profound experience in Trackwise
- Teamplayer Mentality
- English fluently is mandatory
Your benefits
- A very renowned company
- Pleasant working atmosphere
About Hays
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.
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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