Biopharmaceutical Quality Assurance Specialist

1 day ago


Singapore NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD. Full time
Job Description:

We are seeking a highly skilled and motivated Biopharmaceutical Quality Assurance Specialist to join our team at NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD.

About the Role:

  • Support all activities establishing and maintaining Microbiology lab in BioProduction Operations QC, ensuring compliance with cGMP standards.
  • Track and execute individual training requirements, including new methods and instrumentation, to ensure completion on time.
  • Perform microbiological testing and EM sampling in accordance with current testing monographs/SOPs and local/international regulations.
  • Ensure laboratory operations are efficient and effective, with a focus on quality and safety.
  • Support the optimization of work flows in the QC Micro/EM Laboratory, promoting continuous improvement.
Requirements:

To be successful in this role, you will need:

  • A minimum Diploma with 4 to 5 years of relevant working experience, preferably in a cGMP environment.
  • New entrants to the biopharmaceutical industry are welcome to apply, as long as they do not hold a bond obligation with any organisation.
  • Related experience should be in GMP-regulated industries in Quality Control.
  • A background knowledge of analysis such as Bioburden and Endotoxin testing is required.
  • Preferrably a working knowledge of FDA and ex-USA regulatory requirements, as well as industry quality management tools, standard, and quality systems.
Estimated Salary:

S$80,000 - S$120,000 per annum, depending on experience.



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