QA - Document & Record Control Assistant Specialist

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

Manage the complete document management lifecycle where formal change control needs to be demonstrated. All actions and notifications associated with Change request, review, approval, publish, document register, change history are well managed. Assist Engineers in preparing for product release.

Main Responsibilities

• Responsible to follow all applicable SOPs and WIs at all the times.
• Responsible to follow the principle of GMP to the best of their ability at all times.
• An assistant specialist is capable of handling entry level tasks & required proper assistance to perform tasks.
• Assign above job tasks by staffing qualification / personal ability / organization needs.
• Carry out other duties as assigned.

Minimum Qualifications

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

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.