Details
Category: Pharmaceutical- Location: French part of Switzerland
- Starting date: Feb 28, 2019
- Domain of experience: Validation and Qualification
- Level required: Middle
- Years of experience: 5
Your Role
As the Validation and Qualification Engineer you will ensure that the manufacturing processes (including equipment, instruments and analytical methods) are appropriately qualified and validated, prepare and review the related documentation, lead quality risk assessment and change management activities.
Your Tasks
- Lead and work on equipment qualification, cleaning and process validation activities
- Manage deviations arose during validation activities by conducting investigation, escalation if needed and propose corrective and preventive actions
- Ensure that all validation activities are carried out, reported and closed according to plan (time, cost and resources).
- Act as Subject Matter Expert (SME) for change management process in the factory to ensure validated state of the manufacturing processes, methods and systems is maintained
- Act as SME and support for Quality Risk Assessment
- Share expertise and knowledge with business owners and stakeholders (also through training initiatives), develop cross-functional and cross-departmental staff within projects and validation teams
- Assist during audits to ensure compliance
Your Profile
- Bachelor's or Master's Degree in Biology, Physics or Engineering
- Substantial experience in Quality Assurance (QA) and validation of equipment, instruments, analytical methods in the tobacco, food or pharmaceutical industry Knowledge of relevant standards (ISO, Guidance for Industry Process Validation: General Principles)
- Proficient in Microsoft Office Package (World, Excel, Power Point), Office Suite and Microsoft Project
- Fluent in both written and oral English and French.