Technical Writer
Technical Writer
25/11/22
Location
Technologiepark-Zwijnaarde 21, Gent, Belgium
Vacancy
About the job
Our Team
To strengthen our GMP Quality Control team we are looking for a dynamic collaborator with a passion for quality. The primary focus of the technical writer is to edit and write clear analytical plans and reports on a broad range of GMP QC activities such as release and stability testing of a commercial NANOBODY® program.
The GMP QC lab is responsible for method qualification/validation, QC release testing and executing stability studies on drug substance, drug product and placebo batches.
Main responsibilities
You write, review and finalize the study plans and the final reports for the release testing, stability studies, method validation and any other studies performed in the GMP laboratory in close collaboration with the scientist and analysts.
You ensure the GMP documents are of high quality wrt scientific content, clarity, consistency, format (e.g. stability protocols/reports, PPQ protocols/reports, critical reagents protocols/reports etc.) with some/limited guidance.
You ensure that the finished document is complete and accurate and complies with the local and global Quality System.
You contribute to continuous improvement of GMP documents.
You propose scientific conclusions on the analytical data from (u)HPLC, capillary electrophoresis, UV spectrophotometry, moisture content, osmolality, pH, Biacore, particle counting, … generated in the GMP QC lab, in alignment with responsible senior scientist.
You write and follow-up quality-related documents such as change controls, deviations, …
You develop and maintain templates to standardize the GMP documents.
You manage and follow up the timely finalization of the documents, planning the review cycles up to finalization.
About you
Qualifications/ Education & work experience
Bachelor/master with minimum 3 years of relevant experience
Strong skills in document management and management of review/approval cycles
MS Office: proficient level
Fluent in English, written and spoken, preferably fluent in Dutch as well
You combine technical expertise with writing skills
You have experience in physico-chemical analysis and/or potency testing of proteins (such as (u)HPLC, capillary electrophoresis, UV spectrophotometry, moisture content, osmolality, pH, Biacore, particle counting, …)
Experience with technology transfer, method life cycle management, stability studies and release testing in a commercial setting is an asset
Experience with GMP guidelines and a GMP working environment
Knowledge of ICH and Pharmacopeia
Team player, enthusiastic, independent and self-motivated
Excellent communication and writing skills are required
Sense for initiative, quality, accuracy and detail
Pursue progress, discover extraordinary.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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