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
Quality and Technical Guidance
- Oversee programs to support Visual Inspection Operations at the Drug Product facility.
- Execute daily operations, including, but limited to:
- Providing Quality Oversight and guidance during on-the-floor manufacturing
- Executing daily on-the-floor duties to ensure facilities, equipment, materials, and documentation comply with SOPs and safety standards.
- Performing Quarantine and Segregation of material.
- Performing line clearances activities.
- Perform Acceptable Quality Level (AQL).
- Review procedures, documents and records, including but not limited to Batch Production Records, and Protocols.
- Ensure that EBR/Batch Records are complete, accurate, and documented according to the written procedure. Quality support in electronic batch record creation, review, and approval.
- Author/Review/ Quality documents, such as Standard Operating Procedures (SOP’s), Risk Assessment (RA), training materials, training documents, protocols and reports.
- Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
- Identification and implementation of continuous improvement opportunities within our processes and systems and contribute to the continuous improvement culture.
- Maintain project timelines associated with initiatives to support the evolving business.
- Responsible for ensuring that product quality issues are correctly investigated, and that appropriate corrective and preventative actions are implemented. Review deviation/exception/ investigation reports.
- Supports management to implement and maintain the following programs, Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Roche Global document assessments required to be performed at the site level.
- Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing.
- Support the compliance, regulatory and training activities as required
Education/Qualifications
- The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline.
Job Required Competencies
- A minimum experience of 3 years in pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
- Aseptic Filling experience is required.
- Ability to apply a phase appropriate, risk-based approach to QA operational decisions.
- Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System.
- Ability to work well independently and within a team.
- Strong follow-up and organizational skills.
- Fluent oral and written communication skills in English with technical writing experience required.
- 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.
