Nieuw item

CMC documentation analyst

Bedrijfsnaam

A scientific insourcing service provider in the pharmaceutical industry.

Locatie

Leiden

Bedrijfsprofiel

Our client is a scientific insourcing service provider in the pharmaceutical industry.
It is part of the internationally operating organisation. With more than 400 labs and more than 45,000 colleagues, they are world leaders in the field of analyses for BioPharma, Food, Environment and Clinical Diagnostics.

Functie omschrijving

The CMC documentation Analyst will have the next responsibilities:
• Documentation including editing, proofreading, formatting, problem solving of challenges, while ensuring documentation integrity and electronic record compliance, interpretation of current regulatory agency guidelines and implementation into submission documents
• Support of CMC Scientists including resources, coaching, software training, editing clinical and marketing applications, translating technical ideas/thoughts into process documentation
• Representation in the global CMC expert community including application of software

Profiel kandidaat

• You have a Bachelor education with some years of working experience or a Master education, preference for Life Sciences, biomedical sciences, pharmacy or chemistry studies
• Experience with large molecules especially in virology, microbiology labs will put you high on the list
• You have knowledge, experience with, or interest to become an expert in:
o Dossier planning, manufacturing processes and standards
o Specific dossier sub-processes and assignments involving scanning and templates
o General understanding of product development and how organizational functions contribute to the dossier production process
o Analysis and interpretation of data needed for resolution
o Project management of various CMC teams.
• Intrinsic drive to be very accurate, complete and to improve Quality of documents

Uitdaging

A responsible and challenging position with a lot of diversity
• Lots of space for your own ideas and input
• Subject-specific training and opportunities for personal development and education
• Flexible working hours
• Good primary and secondary employment conditions
• Development opportunities in the Netherlands and abroad

Contactpersonen

Ingrid Seifert, Sr. Recruitment Specialist
Mobile: +31 6 11 062 817
E-mail: seifert@my-recruitment.com

Locatie

Leiden

Opdrachtgever

Anoniem

Meer details
Match criteria
Medewerkers
Ingrid Seifert
Mobiel: (06) 1106 2817
Vacatures
Eurofins Bactimm
inNijmegen
Caldic Benelux
inHemiksem
Eurofins Bactimm
inNijmegen
Contact

MY Recruitment
De Lingert 5163
6605 DD WIJCHEN

+31 (0) 24 373 10 71
info@my-recruitment.com

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