QA Specialist Deviations
hace 3 semanas
1996 In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career within clinical development- Your Key responsibilities:- Perform and deliver Quality Operations services for Major Deviations and Transport deviations management to support regulatory submission & variation tracking and audit support.- Responsible to open, manage and follow-up the investigation report for closure of Major deviations for Sandoz products manufactured by a third party, in accordance with company and regulatory requirements.- Responsible for smooth handling of Major Deviations with appropriate project management skills. Responsible to comply with timeliness in accordance with global SOP´s.- Responsible for the extraction and data compilation for preparation of dashboards for all Major deviations open by QSC in the different systems (AQWA, Trackwise or 1QEM) to track and report the deliverables and perform follow-up actions if required.- Escalate service related GxP and non-GxP issues to appropriate level to ensure timely investigation and compliance with local and global operating procedures.- Responsible for writing and updating applicable SOP's.- Demonstrate customer oriented/service mindset in handling and execution of deliverables.- Support service harmonization efforts, implementing service quality, turnaround time to customer feedback and improvement projects. Responsible to stablish and maintain the KPI´s within the quality standards.**Commitment to Diversity & Inclusion**:- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._**Minimum requirements**- #Orbit- Graduate / Post Graduate in Engineering/Pharmacy/ Science/Statistics or related fields- Fluent English and Spanish. Portuguese will be added advantage- At least 3 years in the Pharmaceutical Industry or similarWhy Sandoz?- 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.- How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying- Imagine what you could achieve here at Sandoz**Division**- SANDOZ**Business Unit**- Commercial OPS SIR SZ**Country**- Mexico**Work Location**- Distrito Federal**Company/Legal Entity**- SDZ MEX**Functional Area**- Quality**Job Type**- Full Time**Employment Type**- Regular**Shift Work**- No**Early Talent**- Yes
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