Jobs Companies Roche Formulation Operator/配液操作工-无菌制剂(正式工)

Sobre este puesto de Formulation Operator/配液操作工-无菌制剂(正式工) en Roche

Roche · Presencial · Shanghai

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

Engineering Project Support and Operation Readiness: 

  • Participate in new facility design and construction, including but not limited to process design, FAT, SAT, IOPQ, APS etc. to contribute to project delivery.  

  • Support the initial development and optimization of thawing and formulation processes.

  • Participate in the implementation of operation readiness, eg: draft equipment operation procedures and logbook, 5S, machine cleaning according to readiness plan.

  • Trained and qualified on equipment operation and procedure.

  • Perform other duties as assigned.

Routine Operation: 

  • Ensure routine operation in compliance with Roche’s GMP/SHE and regulation requirements.

  • Performing the following tasks: e.g. biological drug substance thawing, compounding, formulation, mixing, and filtration.

  • Diagnose and resolve equipment malfunctions promptly with the support of maintenance engineers to minimize downtime.

  • Execute regular validation activities, such as APS.

  • Ensure data accuracy, integrity, and traceability for the activities in the GMP area.

  • Related IT system operations, such as SAP, MES, Veeva, Cornerstone.

  • Perform other duties as assigned.

Education/Qualifications 

  • Senior high school and technical School (Pharmaceutical / Biological is preferred) and above.

Job Required Competencies

  • Operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred.

  • Basic understanding of the various factors that affect the quality of biopharmaceuticals.

  • Experienced in strategic projects of Aseptic production facilities including design, commissioning & qualification,single use technology is preferred.

  • Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry. 

  • Basic communications skills in English is preferred and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.

 

 

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.

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Sobre Roche

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.

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