(Sr.) Quality Assurance Specialist (高级) QA 专员

Job description

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. The PositionQuality 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, QC, warehouse or GMP utility & facility ○ Executing daily on-the-floor duties to ensure facilities, equipment, materials, operations and documentation comply with SOPs and safety standards. ○ Performing Quarantine and Segregation of materials. ○ Performing line clearances activities. ○ Perform Acceptable Quality Level (AQL) visual inspection. ● Review documents and records, including but not limited to batch production records, batch testing records, data sheets and protocols. ● Ensure that the records and data are complete, accurate, and documented according to the written procedure. ● Author/Review/Approve 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 QA processes and systems and contribute to the continuous improvement of culture. ● Maintain project timelines associated with initiatives to support the evolving business. ● Responsible for ensuring that product quality events are correctly investigated, and that appropriate corrective and preventative actions are implemented. Review deviation/exception/ investigation / /OOS&OOE&OOT 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, other related duties as required Who we areA 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.