【Company Overview】
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.
【Job Overview】
Provide support and lead SHL Quality management, ISO Laboratory Management and systems management to the Process Development - Analytical Sciences group.
【Main Responsibilities】
Manage Documentation and compliance of ISO 17025 Laboratory Management related tasks.
To play a vital role in liaising with external testing laboratories and vendors, including vendor auditing.
Support Quality Management related tasks such as, Documentation, Materials Management, Sample management, and Vendor Management.
Manage, troubleshoot, and PD/PDAS related database management, report management, programming, code maintenance
Assist in establishing PDAS documentation control process and general PD Process governance.
【Skills and Qualification】
A Bachelor’s degree preferably in Science, Engineering or a technical field.
Desirable to have experience in ISO and other regulatory standards.
Basic experience in coding, E.g. R, Python, and PowerBII is desirable but not required.
General proactive learner to assist in organizing various support needs, including code maintenance and general troubleshooting, in PDAS.
Not afraid to communicate in English (written, verbal) .
ISO training or related training will be provided in accordance with Laboratory Management requirements.