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