Job Description

Summary This role will be responsible to establish and ensure testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are accordance with written testing SOP\xe2\x80\x99s and local/international regulations.QC Specialist IIAbout the Role:This role will be responsible to establish and ensure testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are accordance with written testing SOP\xe2\x80\x99s and local/international regulations.Key Responsibilities:

• 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
• Support in supplier qualification, trending and analysis of KPI/KQI.
• Support sample planning and sampling execution.
• Stability testing (projects) \xe2\x80\x93 protocol preparation, evaluation, report preparation
• Reporting (stability plan preparation, trend analysis, evaluation)
• Performance of stability studies, protocols and comparative reports for supplier qualification.

Essential Requirements:

• 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.
• 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

Desirable Requirements:

• University degree or equivalent experience in Pharmacy or Chemistry or equivalent + 0-4 years working experience

Why Novartis: Our purpose is to reimagine medicine to improve and extend people\xe2\x80\x99s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou\xe2\x80\x99ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewardsJoin our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.Skills Desired

Novartis