质量专员（轮岗培养）

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Support the daily operations of the SQM and Quality Processes teams while also rotating through various departments within the Quality Department. This rotation aims to familiarize with the responsibilities of different quality functions and to make meaningful contributions, with the goal of becoming a future talent in quality management. The rotation will include, but is not limited to, departments such as QC, QA, QS&C and Affiliate Quality.

Your opportunity in the rotation circle:

1. SQM and Quality Processes

• Assist in Quality Risk Management, ensuring QRM process is well maintained for PT China operations following the requirements of relevant GMP/GSP regulations and Roche global standards.
• Assist in monitoring Quality metrics, organizing Quality Council activities.
• Assist in providing quality and compliance oversight for external GxP suppliers to ensure compliance with cGMP and Quality Agreement requirements.
• Support China compliance activities, policy advocacy topics, related working groups and external interactions.

2. QA

• Ensure on-time API/material batch disposition and product batch disposition per requirement.
• Execution of frontline QA activities in plants.
• Coordination and handling for quality related event, ensure the investigation completed within specified due date and supporting products release.
• Support quality oversight on outsourced production related GMP activities in CMO site.

3. QC

• Inspect and analyze materials and finished products, and provide timely and accurate analysis results and reports.
• Assist management of the routine sample, reference standard, stability study sample. Implement analytical method validation, instrument maintenance and calibration.
• Managing validation, qualification, and transfer and troubleshooting of analytical methodologies according to current requirements and regulations.

4. QS&C and Affiliate Quality

• Assist in QMS execution and regulatory compliance across PT China,
• Assist in management of GMP document and record, Change Control, regulation implementation, inspection and audit readiness.

Who you are:

1. Education/Qualifications

• Bachelor’s Degree required, higher-level Degree is preferred.
• Fresh graduates and within 1-year working experience are both acceptable.
• Major in Pharmaceutical, Chemistry, Biochemistry, Bio-engineering or relevant disciplines.

2. Job Required Competencies

• Good knowledge of Quality System and Compliance principles, practices and standards for the pharmaceutical industry.
• Good knowledge of cGMP relevant to the pharmaceutical industry, knowledge of the local and international GMP regulations.
• Good Learning & Adaptability and Teamwork & Collaboration
• Good Accountability and Proactiveness
• Good at English, listening, speaking, reading and writing.CET6
• Good at office software: Word, Excel, Power Point, AI.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.