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
Principle Roles& Responsibilities
Leadership& People Management
- Build and retain an inclusive workforce and foster an environment where diversity of thought and perspective are valued.
- Maintain an inclusive team that values diversity of thought.
- Maintain strong partnerships with leaders to ensure alignment on strategic projects and daily operations.
- Take the responsibility for department daily SHE management, implement site SHE procedure and program, and achieve site corporate /site SHE KPI. Promote SHE culture and improve employee safety behavior.
- Manage performance and development team members to achieve organizational goals and employee personal and professional growth.
- Support manager to build a strong pipeline of talent and robust succession plans for key positions.
- Maintain a culture of continuous improvement and model lean leadership principles.
- Maintain a culture of transparent, high performance, empowerment and innovation culture.
Technical
Engineering Project Support and Operation Readiness:
- Participate in new facility design and construction, including but not limited to process design, equipment selection, URS review, FAT, SAT, IOPQ, APS etc. to contribute to project delivery.
- As a key role, support to establish an effective operation system in alignment with the Roche’s standards, including manufacturing system, CCS strategy, people training and qualification system.
- Lead to establish the procedures related to aseptic techniques, good aseptic practices on the shop floor, and other relevant processes for aseptic production execution.
- Participate in CCS strategy implementation in operation to ensure a sustaining sterility assurance program setting up.
- Support the filling manager to establish the site aseptic training program and implement it, ensure only qualified people perform GMP lots’ manufacturing.
- Ensure team's competencies in performing the following tasks: e.g. vial washing, depyrogenating, filling and stoppering, crimping.
- Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing.
- Perform other duties as assigned.
Routine Operation:
- Ensure routine operationcompliance with regulations, maintain sterile conditions, and achieve high-quality production standards.
- Ensure total readiness of manufacturing suites, including housekeeping, machine, materials, documents and other resources to ensure product delivery in time and within budget.
- Arrange the filling shifts in routine production, participate in operation as an aseptic SME and perform daily review of production batch record, deviation according to schedule.
- Lead annual aseptic operators’ qualification, provide on-the-job training to support formalized technical and GMP training.
- Oversee the daily operation, monitoring, and maintenance of filling equipment to ensure compliance with aseptic requirements.
- Supervise aseptic operations during production and intervene promptly in case of abnormalities.
- Participate in the response of regulator audit and global quality audit as SME during regulatory inspections and audits.
- Raise deviation and involve the root cause investigation, including appropriate escalation where needed to ensure closure of deviation within the set timeline.
- Raise change control and provide assessment.
- Execute regular validation activities, such as APS.
- Participate in Operational Excellence and Continuous Improvement initiatives.
- Related IT system operations, such as SAP, MES, Veeva, Cornerstone.
- Perform other duties as assigned.
Qualification and Experience
Education/Qualifications
- College’s Degree (Pharmaceutical / Biological is preferred) and above.
Job Required Competencies
- 10 or more years’ operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred.
- 3 or more years’ people management experience.
- Experienced in strategic projects of Aseptic Filling facility including design, commissioning& qualification, Isolator filling line is preferred.
- Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.
- Fluent communications skills in English are preferred and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
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.
