QC Specialist II

at  Novartis

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’s and local/international regulations.

ESSENTIAL REQUIREMENTS:

• 5+ years of relevant industry experience, preferably in a cGMP environment
• Hands on experiences in cell-based bioassay, ELISA (Enzyme-linked Immunosorbent Assay), PCR (Polymerase Chain Reaction)
• cGMP knowledge and understanding of manufacturing, quality control, and validation requirements and activities will be advantageous.
  Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s 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-culture
  You’ll 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-rewards
  Join 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.
  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
  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: https://talentnetwork.novartis.com/network
  Division
  Operations
  Business Unit
  Pharmaceuticals
  Location
  Singapore
  Site
  Tuas South Avenue
  Company / Legal Entity
  SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd
  Functional Area
  Quality
  Job Type
  Full time
  Employment Type
  Regular
  Shift Work
  No
  Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

ABOUT 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’s and local/international regulations.

KEY RESPONSIBILITIES:

• Establish and maintain QC Biochemistry lab in full cGMP-compliance.
• Review and validate product testing results and analysis under cGMP and meet required timelines.
• Provides technical support to run and validate necessary test methods on lab equipment and resolve day to day lab operations including troubleshooting of lab equipment and processes.
• Coordinate and implement short to mid-term projects by collaborating with other functions to achieve team goals. Reviewing and Approving method transfer/validation protocols and reports
• Monitoring and optimization of workflows and methods/procedures, drug substance control, method controls and reference’s and perform trending of on-going in process control data to pursue an on-going quality assurance program
• Review/Approve all lab related QA/QC documents to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs.
• Recommend and execute improvements to current processes or systems including creating new test procedures to deliver set KPIs.
• Prepare and participate in health authorities’ inspections and internal audits in respective area. Support and supervise team on day-to-day lab operations as and when required.