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Location

Singen (Hohentwiel) | Germany

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Job description

Ihre Aufgaben:

• 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

Ihre Qualifikationen:

• 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

Ihre Vorteile:

• Working in an internatioal company

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Job tags

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Salary