Biopharmaceutical Quality Assurance Specialist
1 day ago
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.
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.
S$80,000 - S$120,000 per annum, depending on experience.
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