Location: Ivrea, Italy

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 Gx P and HSE guidelines. Performs review and approval of analytical data.

Role Responsibilities:
Operational

• OOx/deviation handling
• CAPA definition/KPI trending
• Ensure all activities in compliance with c Gx P, incl. data integrity
• Review and approval of analytical data / tests (analytical release)
• Maintain and calibrate equipment incl. plan preparation
• Support sample planning and sampling execution
• Stability testing (projects) – protocol preparation, evaluation, report 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:
Relevant Experience

• 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 Gx P 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? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

International

Innovative Medicines

Italy

Ivrea

IT58 (FCRS = IT058) AAA Italy Srl.

Research & Development

Full time

Regular

No