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 II - AnalyticalAbout 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:

• Sample storage and management.
• Analytical testing and documentation of API / drug substance / drug product / finished product / Complaints / stability / packaging material samples
• Ensure all activities in compliance with cGxP, incl. data integrity
• Stability (when not centralized)

• Testing/Sample storage and management
• Analytical documentation of stability samples to cGxP standards
• Detect and report potential accident, risks and propose solutions

Essential Requirements:

• Preferred: Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production), aseptic technique.
• Administrative activities and GMP and HSE-compliant, efficient production and documentation of standardized tasks in the infrastructure
• Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
• 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 Continuous Learning, Gmp Procedures, Managing Ambiguity, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technical Knowledge

Novartis