摘要
About the Role
Key Responsibilities:
• Ensure all activities in compliance with cGxP, incl. data integrity
• Review and approval of analytical data / tests (analytical release)
• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support exception investigations
• Review and approval of production, QC, and AS & T records
• MBR review. Support OpEx improvement projects. Executes batch release in compliance with registration (if Qualified Person)
• 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
Role Requirements :
Essential Requirements:
• 5+ years of experience in pharmaceutical quality control, quality assurance or production
• Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
• Collaboration; result-oriented. Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy
• MS Office applications and other standard IT applications supporting Quality activities
• Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Quality Control (QC) Testing
Desirable Requirements:
• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
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? http://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
