Our client is developing a Medical Devices and is based near Lausanne.
You will be responsible for providing both technical leadership and line management across all Computerised System Validation activities.
Your main activities will be focused on :
- Be responsible for development, preparation, collation or control of all CSV documentation to deliver continued compliance with GMP, ISO9001 / ISO13485 standards, FDA / EU Regulations and approved Health & Safety policies
- Understands business processes / products and needs of internal / external customers and looks to align service provided with these
- Leads projects or project steps within a wider project and has accountability for ongoing activities and / or objectives
- Responsible for management of compliance during all phases of software development life cycle (SDLC) including but not limited to design, specification, procurement, project planning, validation, operation and through to ultimate retirement.
- Interface directly with IT, Engineering, QC, Manufacturing and QA teams to provide advice and assist in resolving compliance issues.
- Collaborate with other sites / facilities and their internal and external partners to lead activities to ensure consistent application of software validation concepts and quality systems / processes
- Supervision and oversight of contractors and intern activities
- Participation in internal and external audits (regulatory and client)
- Participate in review, interpretation, approval and reporting of data trends originating from group operations
- Acts as a coach to support training and development of team members within a learning environment
- Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements including statutory Health & Safety legislation and internal practice.
Your Profile :
- Graduated with a Bachelor/Master degree in science or equivalent Engineering diploma
- Minimum 7 years CSV experience in regulated environment
- Validation experience in global IT softwares validation (ERP, MES, LIMS,…) applied in pharmaceutical or Medical device industries
- Strong knowledge on European and FDA standards dealing with computerized systems
- Ability to work in fast moving environment, maintaining focus on goal and achievement thereof
- Must be able to communicate in a clear and concise manner
- Good report writing skills
- Fluent in English, French is a plus