CMC Change Manager in Teilzeit (m/f/d)
Your responsibilities
- Manage change controls and CMC filing submissions for defined portfolio of products manufactured at CMOs
- Function as the primary interface between department stakeholders and CMOs related to changes and CMC filings for the product portfolio
- Coordination and execution of change controls in Quality System
- Cooperation with Regulatory Affairs regarding Change Control, Notifications, Renewals of Registrations
- Writing and compilation of CMC documents including processing of the CMC Module 3 document sections for products in scope
- Liase with department colleagues, CMOs, and Regulatory Affairs to obtain all required information and documentation to support changes and related CMC filing updates
Your profile
- Degree in Pharmacy, Chemistry, Biology, Process Engineering or equivalent Professional experience
- Profound experience in project management, production, QA and/or QC within the pharmaceutical industry
- Experience with CMC writing, specifically eCTD Module 3
- Good knowledge of regulatory requirements regarding manufacture of medicinal products
- General understanding of pharmaceutical business (incl. technical pharmaceutical knowledge, regulatory, legal and commercial aspects)
- Knowledge about GMP regulations and requirements
- Experience in collaboration with contract manufacturing organizations Competences/skills
- Good collaboration skills, organized, results-oriented as well as structured and able to prioritize tasks
- Ability to solve complex situations and problems
- Cultural awareness: ability to build good relationships across cultures internally and externally, nationally and internationally
- Knowledge of GMP, GDP and quality systems
- Fluency in verbal and written English MOs related to changes and CMC filings for the product portfolio
Your benefits
- Working in an internatioal company
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 a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Your contact at Hays
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