About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The assistant specialist will work with Quality Assurance to assist the compliance activities of developing and manufacturing processes. Complete duties assigned by supervisor, such as handling records/ documents, training new staffs, supporting continuous improvement projects, implementing quality control standards, and adhering to legislation requirements. 

Main Responsibilities

• Review data, validation protocols/documents, manufacturing records, specifications, and manufacturing documents for compliance.
• Develop and maintain standards for inspection
• Ensure the compliance of product manufacturing and product release processes
• Support processes to streamline and implement the new system as needed.
• Create/ Maintain SOPs as needed.
• Follow GMP guidance and adhere to SOPs and GMP requirements.

Minimum Qualifications

• Ability to communicate appropriately and accurately both orally and in writing the progress of assignments
• Able to work on documentation processing & data reviewing.
• Proactive, eager to learn new things, and has good communication skills in both English and Mandarin
• Proficiency in Microsoft Office Programs

Preferred Qualifications

• <1 year experience in a regulated environment (GMP) is preferred.
• <1 year experience in Quality Assurance is preferred.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.