QA Software Consultant

Lausanne  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Description

For my client I am currently looking for a QA Software Consultant, for a leading pharmaceutical company in the Lausanne area.

Please find below additional information.

General Information

This is a project based in the french part of Switzerland for a 12 month contract. Your task will be to act as quality management representative in selected development projects, in the field of e-health software, including web-based, and mobile applications:

Tasks
  • Ensure design control compliance in accordance with ISO 13845 and 21 CFR 820
  • Provide expertise in compliance related to cloud computing
  • Identify the applicable quality and regulatory standards
  • Review and approve all project deliverables (internal and from suppliers), including software requirements, specifications, verification and validation documents
  • Participate to risk management and software development activities in accordance with ISO 14971, IEC 82304 and IEC 62304
  • Participate to design reviews, approves/disapproves move to next phase
  • Participate to supplier qualification and audits
  • Review and approve change control, deviations and CAPAs


Skills:

Cloud Computing

(excellent), > 5 yrs

Data Integrity

nice to have

Documentation skills

(excellent), > 5 yrs.

IEC 62304

(excellent), > 5 yrs.

ISO CFR 820

(excellent), > 5 yrs.

Software Development, V&V

(excellent), > 5 yrs.

Software as Medical Device

(excellent), > 5 yrs.

English

business fluent

GAMP 5

nice to have

As the manager needs support urgently, I would like to ask you to send me your updated CV.

Looking forward to a successful cooperation.

Sebastian Spaniol
s.spaniol(@)realstaffing.com
Start date
02/2017
Duration
12 Months
From
Real Staffing
Published at
14.01.2017
Project ID:
1268750
Contract type
Freelance
To apply to this project you must log in.
Register