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 / Accountabilities
Engineering Project Support and Operation Readiness:
- Collaborate with cross-functional teams to implement GMP-related systems, processes, and workflows for the production department.
- Develop and implement GMP training programs tailored to production staff, aligned with corporate quality policies and regulatory requirements.
- Establish the deviation management and CAPA processes in manufacturing for handling non- conformances effectively and ensuring timely resolutions.
- Implement a robust change control process, ensuring GMP compliance and proper documentation of changes in the production environment.
- Participate in the preparation for facility qualification audits and regulatory inspections, ensuring that all systems and practices meet GMP standards.
- Lead consumable materials/service introduction and track the status to ensure to meet the manufacturing requirement.
- Support the development of GMP documentation including SOPs, validation protocols, and project-specific documentation for compliance.
- Perform other duties as assigned.
Routine Operation:
- Ensure routine operation in compliance with Roche’s GMP/SHE and regulation requirements.
- Serve as the primary interface between the production department and QA/Compliance teams for GMP-related matters.
- Manage ongoing GMP training programs, ensuring production personnel are regularly updated on GMP and compliance requirements.
- Oversee the timely identification, investigation, and resolution of deviations, ensuring proper execution of CAPAs to avoid recurrence.
- Evaluate and coordinate changes within the production department, ensuring proper implementation and documentation in line with regulatory requirements.
- Act as the production department’s primary liaison during internal and external audits, ensuring inspection readiness and addressing observations.
- Monitor GMP compliance in daily operations, identifying gaps and implementing corrective actions.
- Proactively identify areas for improvement in GMP operations, driving initiatives to enhance quality and productivity while maintaining compliance.
- Perform other duties as assigned.
Qualification and Experience
Education/Qualifications
- Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above.
Job Required Competencies
- 5 or more years’ operation experience in GMP compliance roles in the injection pharmaceutical industry, MNC Bio-pharma preferred.
- Experienced in strategic projects of facility including design, commissioning qualification is preferred.
- Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.
- Hands-on experience in deviation handling, CAPA management, change control, and audit preparation is required.
- Familiarity with compliance tools and systems for managing training, deviations, and CAPAs.
- Fluent communications skills in English is 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.
