Major accountabilities:

• Assistance on the implementation of national and international standards and guidelines established for requirements of analytical method validation and forced degradation studies (FDS) for finished products;
• Assistance in execution of FDS, method validation and transfer activities for finished products according to current local and international guidelines Novartis standards and procedures;
• Support analysts on activities related to analytical worksheet, protocols and reports, 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 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

Skills:

NA.

Languages :

• English.

Education & Qualification

• Studying Pharmacy, Chemistry, Chemical Engineering or correlated graduation