Associate Manager / Senior Specialist - Quality Assurance

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 Position1.1 Quality Oversight Collaborate with key stakeholders including manufacturing operations, supplier quality, quality systems and Planning; provide Quality oversight in repackaging products and IMP materials life cycle and the E2E process. As per the business arrangement, the scope of quality oversight should cover the quality activities in all related areas including warehouse operation and packaging plants. Manage and oversee frontline QA activities of repackaging products and IMP products in plants. Manage of sampling process for repackaged products Perform oversight of Specification, process and product monitoring for repackaging products Perform oversight of stability program for repackaging products Connection with Global, take role as quality role across the repackaging product life-cycle management. Execution of frontline QA activities in plants and warehouse Acknowledge the live status in production area according to the DPS and follow up with actual excursions against the DPS, identify the potential risks and take preventive action. Join Tier meeting in production and warehouse or other Tier meetings Perform batch record review Enabling real-time problem solving with production and warehouse team 1.2 Implement repackaging and additional labeling IMP product-related batch release process Ensure on-time batch documentation review per the requirement of Roche Timeline. Ensure products are not sold or supplied before a QP/AP has released, each production batch is produced and controlled in accordance with the requirements of the Marketing Authorization and other regulations relevant Additional labeling IMP batch release. 1.3 Execution of direct/ IMPmaterials management Ensure on-time direct material batch disposition per Roche requirement Implement oversight of material quality including Specifications, Artwork, SAP/MES master data, Change, DMS/CAPA, new material qualification, quality management etc. Support local supplier quality management including audit, Quality Agreement etc. Clinical trial material shipping documents check and system release Temperature excursion evaluation during transportation for local sourced IMPs. Support the investigation of repackaging and IMP products complaints. 1.4 Coordination and handling for quality related issue Implement the management of Event &CAPA：Be able to utilize RCA tools and can facilitate related departments to conduct discrepancy investigation, ensure the investigation completed within specified due date and supporting products release. Collaborate with SMEs and Lead investigators to develop investigation strategies Participate in Local Quality Council when needed Monitor investigation progress and ensure effective corrective and preventive actions are initiated and executed on time and keep continuous improvement Handle Customer complaint: Perform customer complaint investigation and ensure effective corrective and preventive actions are initiated and executed on time 1.5 Quality system oversight Execute QA process/documentation maintenance in a continuously compliant state and a continual state of readiness for regulatory agency inspections Manage material quality management in site Manage repackaging of finished products and labeling management for donation products. 1.6 Other quality related activities Support to draft and review the local product APQR. Involve and support the inspection by HA and Roche Global inspection. Involve quality related projects. Document management 1.7 Complete other tasks assigned by senior leaders Key Interfaces Manufacturing, Engineering, Local MSAT, Planning, Warehouse, Safety, Medical and Regulatory affairs Other Quality Functions QMS document owners/authors Global Functions: Regulatory (PDR/PTR), PT Development, TPLs and GxP Supplier Management. Education/Qualifications Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level) Graduate or higher-level Degree is preferred Job Required Competencies Good accountability of GMP understanding and implementing. Knowledge and experience in production and quality management. Well communication skill and good accountability of problem solving. Demonstrate good verbal and written communication skills in English Focus on value and customer Learn for the future 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.