PbJob Description Summary /b /p1. Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibilitybr2. Write review, decide on approval and/or release of GMP-relevant deliverables, as applicable, and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.br3. Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.br4. Support Project management functions as a project team member.br5. Provide support to TRD line functions in GMP related topics as per area of responsibility.br6. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).pbJob Description /b /ppbKey responsibilities: /b /pullipSupport the TRD QA function within a team, providing expertise to Line Units and other QA units in areas of responsibility. /p /lilipWrite, review, and ensure compliance of GMP-relevant deliverables and tools with cGMP standards and project quality requirements. /p /lilipOversee quality assurance for technical activities during development stages, including technical transfers and release requirements. /p /lilipSupport project-related activities such as process development, quality initiatives, risk assessments, facility upgrades, and IT validation. /p /lilipEnsure alignment and consistency of regulatory submissions (IMPD/IND, NDA/MAA) and address health authority queries. /p /lilipAssist clinical trial teams with QA activity timelines and supply chain oversight. /p /lilipPerform QMS-related activities, including training, KPI oversight, SOP maintenance, and audit/inspection support. /p /lilipAct as QA point-of-contact for assigned CMO, including audits, CAPAs, documentation reviews, and compliance monitoring. /p /li /ulpbEssential requirements: /bbr/pullipDegree in Pharmacy, Biology, Chemistry, Engineering, or equivalent. /p /lilipFluency in English (verbal and written). /p /lilipStrong awareness of quality issues and urgency in task completion. /p /lilipOpen and clear collaboration and communication skills. /p /lilipScientific, technical, and regulatory knowledge in the specific area, with basic understanding of drug development. /p /lilipDetailed knowledge of cGMP and familiarity with safety/environmental regulations. /p /lilipMinimum 5 years of experience in pharmaceutical companies in equivalent roles. /p /lilipStrong organizational skills. /p /li /ulpWhy Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: brYou will receive: You can find everything you need to know about our benefits and rewards in the Novartis Life /ppHandbook. brbCommitment to Diversity and Inclusion /b: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. /ppbJoin our Novartis Network: /bIf this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: /ppbSkills Desired /b /pContinued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence #J-18808-Ljbffr