Quality Process Engineer at F. Hoffmann-La Roche Ltd - Poland

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

27 Dec, 25

Salary

0.0

Posted On

28 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality System, Compliance Principles, cGMP, Analytical Skills, Problem Solving, Teamwork, Collaboration, Communication, Accountability, Adaptability, Office Software, English Proficiency

Industry

Biotechnology Research

Description

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 Your opportunity: Primary Purpose of Job 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. Principle Roles & Responsibilities / Accountabilities 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, graduate or higher-level Degree is preferred. 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. Good Teamwork & Collaboration Well communication skill and good accountability of analytical and problem solving. Good Accountability and Proactiveness Good at English, listening, speaking, reading and writing. 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

Support daily operations of the SQM and Quality Processes teams while rotating through various departments within the Quality Department. Assist in Quality Risk Management, monitor Quality metrics, and provide quality oversight for external GxP suppliers.