Be responsible for packaging materials handling including the needles inspection on the packaging line.
Support to perform equipment qualification and process validation on the packaging line.
Be responsible for qualification and manufacturing activities execution with high quality and efficiency.Engineering Project Support and Operation Readiness:
Participate in new facility design and construction, including but not limited to FAT, SAT, IOPQ etc. to contribute to project delivery.
Support the initial development and optimization of packaging 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 CCS implementation in packaging.
Perform other duties as assigned.
Routine Operation
Ensure routine operation in compliance with Roche’s GMP/SHE and regulation requirements.
Performing the following operations: e.g. Needle Cutting and Visual Check, Labelling and Packaging.
Execute regular manufacturing operations and GMP records filling.
Ensure data accuracy, integrity, and traceability in all packaging activities.
Implement cold chain management in the packaging process.
Diagnose and resolve equipment malfunctions promptly with the support of maintenance engineers to minimize downtime.
Related IT system operations, such as SAP, MES.
Perform other duties as assigned.
Education/Qualifications
Senior high school and technical School (Pharmaceutical / Biological is preferred) and above.
Job Required Competencies 岗位所需胜任力
3 or more years’ operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred.
Experienced in strategic project of packaging facility including design, commissioning & qualification is preferred.
Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in 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.
