QA Operations

at  CAPGEMINI ENGINEERING

ABOUT THE POSITION

The Quality Assurance consultant holds a vital and challenging role in any life science company: ensuring the quality and safety of products going to patients through building a Quality Management System.

• Build the Quality Management System (QMS)
• Discover, track and discuss problems, non-conformities and deviations within a production plant, a laboratory, a warehouse & distribution center, …
• Launch, execute and document quality issues & investigations
• Perform root cause analyses to determine the true source of any issue
• Devise CAPAs (corrective & preventive actions) to resolve the problems and prevent it from happening again
• Create or improve operating procedures, work instructions, templates, quality systems, etc… To keep up with an ever-changing world.
• Own change controls , assessing the impact and ensuring the quality and compliance of the business throughout any change
• Give trainings to operators, lab technicians, engineers, … in your new procedures
• Plan, organize and execute the review and approval of qualification reports, test protocols, validation documents, … Together with the engineers and subject matter experts
• Manage or coordinate projects to implement changes within your QMS
• Qualify, approve, monitor and periodically re-evaluate suppliers
• Prepare, assist and even lead internal and external audits
• Collect, analyze and present quality metrics and KPIs to determine the most strategic way forward