Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
Roche is hiring for a greenfield facility in Shanghai and we are looking forLab Support& ASAT SME, for who takes responsibility forequipment/systems qualification and validation, sample and testing material management and other lab supporting processes. Also provides support during the project, operation readiness and start-up phase and liaises across the design, construction, qualification of the QC area, ensuring they meet the intended standard and regulation requirements.
Strong skill and experience are required to cover two areas: Greenfield project and Routine Operation management.
- The role supports on the equipment/system qualification and validation, sample/material management and QC operation readiness and start up.
- Work independently and with a level of autonomy and authority in efficient execution to ensure on-going compliance against approved global/local procedure documents, current Good Manufacturing Practices, and CN/EU Annex-1 during the product lifecycle.
- Enable and self-motivate, and demonstrate leadership behavior and mindset
Principle Roles& Responsibilities / Accountabilities主要职责/责任
Routine Operation:
- Perform the qualification, validation, calibration and maintenance activities for relevant equipment with Roche’s QMS and regulatory guidelines.
- Set up master data according to business requirements and ensure data integrity.
- Adhere to all effective SOPs and safety requirements and document laboratory work consistent with cGMP requirements
- Assist Head of Lab Support to complete GMP Self-Inspection as well as the relevant CAPAs to maintain the global level of GMP compliance.
- Presents technical analytical data clearly and concisely to internal investigations and regulatory inspectors. Accomplish sample and testing materials management(eg account management, DI assessment), to ensure they are in good order to meet the analytical needs any time. Report the abnormal status, deviations to supervisors with initiative.
- By identifying abnormal status and unexpected results during routine operation by detailed data, support to alert supervisors to investigate and solve the problem in correct way and in time.
- Maintain laboratory cleanliness and inventory of bioanalytical materials and cell supplies Supports lean initiatives in the area of lab operations, test method execution, documentation updates and equipment qualification
Engineering Project Support and Operation Readiness:
- Equipment qualification and validation: Support and execute the equipment qualification and validation for the aseptic product.
- Sample and material management: Execute GMP sample management; Execute material inventory management.
- Digital system deployment: Support and ensure on time delivery for QC digital system(eg.LIMS).
Qualification and Experience能力与经验
Education/Qualifications
- Bachelor’s Degree (Life Sciences, Microbiology, or Analytical Sciences is preferred) and above
Job Required Competencies
- 2 or more years of QC experience, QC experience, with a focus on bioanalytical and bioassay testing. MNC Bio-pharma experience is preferred
- Sound knowledge of quality control procedures and legal standards, with experience in aseptic assurance and physical and chemical testing.
- Experienced in QC new system startup readiness and operation ramp up is preferred.
- Fluent communications skills in English
- Project management skills are preferred.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
