5110 - Technical Writer Pipeline Device Development

16-9-2020 braine-l'alleud
job description

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 ? basar.seda@cx.ausy.be


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. 

your contribution

  • Minimum of 3 years working in the pharmaceutical/biologics/medical device industry. Operational GMP or quality experience would be a distinct advantage
  • Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements
  • Demonstrate ability to independently analyse data and information to draw conclusions and make effective decisions
  • Must be able to identify and assess risks together with proposing corrective actions within area of expertise
  • Help others solve problems in a creative and practical way through development of solutions from innovative problem solving activities
  • Experience in GMP and Regulatory Requirements within the pharmaceutical industry
  • Experienced in CAPA management.
  • Root cause analysis and risk management/assessment skills will be a distinct advantage.

what do we offer?

  • AUSY Contrat (Freelance also possible)
  • start date ASAP until end 2020 
  • in Braine-l'Alleud


summary
function
administrative employee (m/f)
employment type
full time, freelance
contract type
long term contracts
reference
CXRSP-91838
your Randstad contact
Seda Basar
basar.seda@cx.ausy.be 0478 63 39 11
0478 63 39 11