Highly skilled and experienced laboratory professional who contributes by performing analytical method validation, forced degradation studies, investigational support and research support.About the RoleMajor accountabilities:Support the implementation of national and international standards and guidelines established for requirements of analytical method validation and forced degradation studies (FDS) for finished products;In charge of execution of FDS, method validation and transfer activities for finished products according to current local and international guidelines Novartis standards and procedures;Responsible for activities related to analytical worksheet, protocols and reports (elaboration and revision), statistical analysis application for analytical method validation and calculation of samples and analytical materials in order to assure that all goods are available and enough to perform experimental tests;Collaborate and provide technical support in case of deficiency letters raised by the Health Authorities, regarding AS&T topics;Support and conduct analytical investigation activities according to the demand, in compliance with local and global procedures, applying properly quality tools in order to identify the root cause and ensuring the implementation of preventive/corrective actions;Collaborate and act actively on the housekeeping program, maintaining the lab clean, organized, standardized, identified according to 6S methodology;Keep equipment and analysis bench clean and organized before and after each analysis, following quality standards and cleaning procedure, assuring the usage of solutions and laboratories supplies within shelf-life;Ensure training matrix assigned in Up4Growth platform to the function/position is fulfilled in order to perform routine activities accordingly.Key performance indicators:Compliance with quality systems and corporate requirementsRight first time in analysis, as well in calculation of samples and analytical materials in order to assure that all goods are available and enough to perform experimental testsEnsure adherence to timelines defined at global/local levels for submissions to projects attributed to AS&T following annual SLA, to accomplish with launches/submissions business prioritiesZero critical findings in local, internal and corporate Quality and Safety audits.Collaborate in the compliance with local and global performance indicators and implement the corresponding actions and/or remediation plans, whenever necessaryEnsure adherence to the ALCOA + principles in routine activities and zero analytical deviation attributed to Data IntegrityWork Experience:Experience in the Pharmaceutical Industry. Previous experience in Development and Analytical Method Validation. Desirable experience in key areas such as Quality Assurance, Quality Control, Stability or Analytical Services. Knowledge in quality systems, risk management and application of local and international sanitary regulation. Desirable experience in project management and budget control.Skills:Solid knowledge in Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and GDocPSolid knowledge in Analytical Method Validation and forced degradation studiesStatistical knowledge for the evaluation of analytical resultsKnowledge in current pharmacopoeias such as USP, EP, BP, JP, etc. local and international requirements.Knowledge of local, regional and international regulatory standards, such as ANVISA, ICH, FDA, EMA, ANMAT.Experience in physicochemical analysis of finished product.Knowledge in quality system, such as change control, deviation investigation, OOS, OOT and OOE in the laboratory.Knowledge in data integrity principles (ALCOA+)Solid knowledge in chromatographic analytical techniques such as: UV/Vis spectrophotometer, dissolution, HPLC, GC. And software such as Empower.Languages :Advanced level in English.Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives.
#J-18808-Ljbffr