Remote Opportunity-Computer System Validation (CSV) Expert
International working environment with remote opportunity
Our client is a multinational corporation that develops medical devices, pharmaceutical, and consumer packaged goods.
- Plan, Perform, and Coordinate Computer System Validation, Equipment Qualification, Temperature Controlled Objects.
- Clean Utility Validation in accordance with the Company's internal procedures and industry standards.
- Create, review and approve equipment qualification and analytical instruments lifecycle documentations.
- Coordinate the commissioning and qualification activities.
- Lead daily validation meetings with cross-functional in resolving validation issues.
- Actively audit projects and systems to ensure that the appropriate validation activities are carried out in compliance with regulatory requirements and corporate standards.
- Knowledge on GxP and Computer System Validation (CSV) , Customer SOP, aware of SDLC and deliverables, - Associated experience in pharmaceutical R&D domain would have an added advantage.
- Excellent communication skill and exposure on handling customers at onsite. Ability to work as a team player in a consulting environment.
- Candidate must be aware of SDLC and deliverables.
- Should have knowledge of Risk Management.
- Candidate reside in Japan.
Dynamic and friendly working environment.
Competitive salary, above 10M/year.
Central location in Tokyo with remote opportunity.
- Individual performance is highly valued, with great chance to make career progression in the company development projects.