PbJob Description Summary /b /pp1. 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 responsibility /pp2. 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. /pp3. 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. /pp4. Support Project management functions as a project team member. /pp5. Provide support to TRD line functions in GMP related topics as per area of responsibility. /pp6. Comply with internal and external guidelines regarding quality and safety (Quality Manual regulatory cGMP guidelines Health Authority guidance SOPs etc.). /ppJob Description /ppbKey responsibilities : /b /ppSupport the TRD QA function within a team providing expertise to Line Units and other QA units in areas of responsibility. /ppWrite review and ensure compliance of GMP-relevant deliverables and tools with cGMP standards and project quality requirements. /ppOversee quality assurance for technical activities during development stages including technical transfers and release requirements. /ppSupport project-related activities such as process development quality initiatives risk assessments facility upgrades and IT validation. /ppEnsure alignment and consistency of regulatory submissions (IMPD / IND NDA / MAA) and address health authority queries. /ppAssist clinical trial teams with QA activity timelines and supply chain oversight. /ppPerform QMS-related activities including training KPI oversight SOP maintenance and audit / inspection support. /ppAct as QA point-of-contact for assigned CMO including audits CAPAs documentation reviews and compliance monitoring. /ppEssential requirements : /ppDegree in Pharmacy Biology Chemistry Engineering or equivalent. /ppFluency in English (verbal and written). /ppStrong awareness of quality issues and urgency in task completion. /ppbOpen and clear collaboration and communication skills. /b /ppScientific technical and regulatory knowledge in the specific area with basic understanding of drug development. /ppDetailed knowledge of cGMP and familiarity with safety / environmental regulations. /ppMinimum 5 years of experience in pharmaceutical companies in equivalent roles. /ppbStrong organizational skills. /b /ppWhy Novartis Our purpose is to reimagine medicine to improve and extend peoples 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 : will receive : You can find everything you need to know about our benefits and rewards in the Novartis Life /ppto Diversity and Inclusion : Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve. /ppJoin our Novartis Network : If 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 : Desired /ppContinued 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 /ppRequired Experience : /ppManager /ppbKey Skills /b /ppAPQP,Quality Assurance,ISO 9001,Lean Six Sigma,PPAP,Root cause Analysis,ISO 13485,Quality Systems,Quality Control,Quality Management,As9100,Manufacturing /ppuEmployment Type : /u Full-Time /ppuExperience : /u years /ppuVacancy : /u 1 /p #J-18808-Ljbffr