Design Control Specialist

2 settimane fa

Milano, Italia Novasyte A tempo pieno

Our client, Chiesi Farmaceutici - one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of Design Control Specialist - Medical Devices - who can join an exciting working environment in a dynamic and international atmosphere.

JOB DESCRIPTION:
The scope of the role is to support the generation, maintaining and archiving of design control documentation in relation to design and development of Drug Delivery Devices or Medical Devices.

RESPONSIBILITIES:

- Support for the generation, review and update of Design Controls Documentation for Drug Delivery Devices or Medical Devices in compliance with the applicable regulatory requirements.
- Support for the generation of technical documentation for the design and development of Drug Delivery Devices or Medical Devices.
- Support of activities of Risk Assessment and preparation and archiving of Risk management file.
- Support to the classification and archiving of technical documentation for the design and development of Drug Delivery Devices or Medical Devices.
- Support in the management of documents relating to the GTD -DEV DEV department in the corporate document system.
- Support to the generation, review and update of SOP and WI in the field of Design Control o Device development.
- Actively participate to work programs with a cross-functional team.
- Support to the planning, preparation and execution of Design Review.
- Support the generation, maintenance and updating of the Design History File Index.
- Support the generation, maintenance and updating of the Device Master File Index.
- Support for the redaction of supportive documentation for the preparation of relevant section of device contents for Technical Dossier, Technical documentation, IMPD, IND, etc for Regulatory purpose.

**REQUIREMENTS**:

- Degree in scientific or technical discipline
- At least 2/3 years of experience in Pharmaceutical or Medical Device companies in the role of Documentation specialist or Quality Assurance / RA Assistant or Design Control specialist.
- Knowledge of Medical Device Regulation, ISO 13485, FDA 21 CFR 820 and 21CFR part 4.
- Precision and accuracy
- Ability in Technical and QA Document redaction
- Quality of written communication, Document redaction, Delivering presentations,
- Ability to work in team
- Time Management, Prioritisation
- English knowledge

TYPE OF CONTRACT:
Maternity replacement

Chemical contract

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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