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Offre d'emploi: 5110 - Technical Writer Pipeline Device Development:Randstad

Job description:

5110 - Technical Writer Pipeline Device Development

16-9-2020 braine-l'alleud

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description de la fonction

AUSY is seeking a Technical writer.  An operational practice in a GMP working environment and good knowledge/practice 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 significant 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. located 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 significant CMC sections of regulatory dossiers.  vos atouts
   » Minimum of 3 years working in the pharmaceutical/biologics/medical device industry. Operational GMP or quality practice would be a distinct advantage
   » Practical knowledge of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements
   » Demonstrate capability 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 skills
   » Help others solve problems in a creative and practical way through development of solutions from innovative problem solving activities
   » practice in GMP and Regulatory Requirements within the pharmaceutical industry
   » practiced in CAPA management.
   » Root cause analysis and risk management/assessment skills will be a distinct advantage.
qu'offrons-nous?
   » AUSY Contrat (Freelance also possible)
   » start date ASAP until end 2020 
   » in Braine-l'Alleud

sommaire

fonction
   . employé administratif (m/f)

type de job
   . temps plein, freelance

type contrat
   . missions à long terme

référence
   . CXRSP-91838
informations de contact
Seda Basar
0478 63 39 11

 

informations de contact
Seda Basar
0478 63 39 11

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: braine-l'alleud, Ander
Address: braine-l'alleud
Company Type Employer
Post Date: 09/17/2020 / Viewed 26 times
Contact Information
Company: Randstad
Contact Email: basar.seda@cx.ausy.be


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