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AUSY is looking for a Technical writer. An operational experience in a GMP working environment and good knowledge/experience in medical devices industry is required.
Consultancy : start ASAP until 31/12/2020, in Braine-l'Alleud (pharmaceutical industry)
more info ? email@example.com
The primary goal of the function is to author reports and templates and manage documentation for device development team, thus supporting activities relating to the device development, transfer , assembly process qualification and clinical/commercial manufacturing support. They will work in a team environment, collaborating with various quality, regulatory, scientific, clinical and manufacturing experts. They will author and review relevant documents that support regulatory license applications and hence have to be of a very high standard. The data to be summarized in the reports will be collected from electronic and physical repositories, verified, cleaned, analyzed and visualized. Based on this, the writer will then generate scientific reports supporting the design history file and regulatory filings (Development and Technical Reports in English) and contribute to the preparation of regulatory submissions with business partners. The reports will be written in English. The technical writer will manage their review and approval in the appropriate electronic document management system. The candidate will also contribute to the data review of the relevant CMC sections of regulatory dossiers.
Minimum of 3 years working in the pharmaceutical/biologics/medical device industry. Operational GMP or quality experience would be a distinct advantage