Role Purpose: Specialist in the area of analytics, supporting the laboratory team with in-depth knowledge to ensure efficient performance of laboratory activities and related investigations in compliance with GxP and HSE guidelines. Performs review and approval of analytical data.
About the Role
Role Responsibilities:
Operational
Ensure all activities in compliance with cGxP, incl. data integrity
Review and approval of analytical data / tests (analytical release)
Maintain and calibrate equipment incl. plan preparation
Performance of stability studies, protocols and comparative reports for supplier qualification
Review and approval of analytical tests (analytical release)
HSE
Comply with all HSE guidelines
Detect and report potential accident, risks and propose solutions
Participate in HSE risk assessments
Preparation and participation to internal HSE audits
Responsible for participating in initial training and retraining
Ideal Background:
Professional experience (3-5 years) in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent; Collaborating across boundaries; Functional Breadth; efficient inter and intra-departmental communications.
Education & Qualification:
Technical education & 3-5 years relevant experience or Desirable University degree in Pharmacy or Chemistry or equivalent + 0-4 years working experience
Languages:
Good (oral and written) in English; fluent in local language (oral and written)
Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
MS Office applications and other standard IT applications supporting Quality activities
Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; Knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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. Ready to create a brighter future together?
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