QC Specialist II

6 days ago


Singapur, Singapore Novartis Full time
Summary

Establish and ensure testing of drug substance release and stability testing, including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOPs and local/international regulations.

About the Role

Key Responsibilities:

  1. Handle OOx/Deviation.
  2. Define CAPA, perform KPI trending, and ensure all activities comply with cGxP, including data integrity review and approval of analytical data/tests (analytical release). Conduct stability testing (projects), prepare protocols, evaluate data, and compile reports.
  3. Prepare stability plans, perform trend analysis and evaluation, and generate reports. Conduct stability studies, review and approve analytical tests, perform microbiological QC, and environmental and personnel monitoring.
  4. Provide expert support for site qualification and validation activities. Maintain and calibrate equipment, support supplier qualification, and trend KPI/KQI data.
  5. Assist in sample planning and sampling execution. Report technical complaints, adverse events, and special cases related to Novartis products within 24 hours.
  6. Distribute marketing samples where applicable.
  7. Comply with all HSE guidelines, report potential risks, participate in risk assessments, and internal audits. Participate in initial and retraining programs.
Essential Requirements:
  • Over 6 years of professional experience in the pharmaceutical sector or active substance manufacturing in a GMP environment or equivalent. Strong collaboration, communication, and result-oriented skills. Knowledge of TQM and GxP standards. Proficiency in MS Office and laboratory equipment.
  • Experience in QC testing, sampling, and quality decision-making.
Desirable Requirements:
  • Technical education with 3-5 years relevant experience or a university degree in Microbiology, Biochemistry, or related fields, with 0-4 years of working experience.
Why Novartis:

Helping people with disease and their families requires more than science. It takes a community of passionate individuals working together to make a difference. Join us to create a brighter future:

Join our Novartis Network:

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Benefits and Rewards:

Learn about our support for your growth:

Division: Operations | Business Unit: Innovative Medicines | Location: Singapore, Tuas South Avenue | Company: SG12 (FCRS=SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd | Job Type: Full-time | Employment Type: Regular | Shift Work: No

Novartis is committed to building an inclusive and diverse work environment that reflects the communities we serve.

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