Major 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;
• Support and handle technical discussion with global AS&T, manufacturing sites, ESO, TRD, Regulatory Affairs, Project Managers, Third Party Laboratories;
• Collaborate in internal and external audits related to AS&T and QC and establish CAPA plans for the findings, whenever identified. Follow up CAPA implementation in a timely manner;
• 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 requirements
• Right 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 tests
• Ensure 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 priorities
• Zero 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 necessary
• Zero accidents
• Ensure adherence to the ALCOA + principles in routine activities and zero analytical deviation attributed to Data Integrity

Minimum Requirements:

• A bachelor’s degree related to the Pharmaceutical area, Chemical or Biological, titled with a professional license.
• >5 years experience in Pharma/Manufacturing sector in analytical lab

Work 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 GDocP
• Solid knowledge in Analytical Method Validation and forced degradation studies
• Statistical knowledge for the evaluation of analytical results
• Knowledge 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.
• Extensive 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 MS-LS. And software such as Empower.

Languages :

• Fluent in English.