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上海市, 中国
Onsite
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
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.
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.