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Senior Microbiologist

2 months ago

Singapore CORESTAFF PTE. LTD. Full time
About the Company

CORESTAFF PTE. LTD. is a leading provider of sterile pharmaceutical ophthalmic solutions, dedicated to advancing wellness in hospitals, clinics, and home-care sectors.

Position Overview

The incumbent will provide supervisory and testing support to the Quality Control Microbiology laboratory in sterility testing, environmental testing, bioburden testing, validation activities, and ensure Standard Operating Procedures (SOPs) comply with applicable ISO standards, regulatory requirements, and compendial testing methods.

Key Responsibilities
  • Perform and supervise all microbiological testing as required, including sterility tests, total microbial count, particulate count, growth promotion tests, gram stains, endotoxin tests, environmental monitoring, etc.
  • Provide guidance and coaching to laboratory technicians on microbiological testing and environmental monitoring.
  • Ensure all microbiological laboratory resources are utilized productively with laboratory goals and priorities.
  • Supervise the environmental monitoring program and ensure its effectiveness.
  • Promote awareness with impacted departments on the control of the sterility assurance of products and manufacturing processes.
  • Work with various departments to ensure the sterility assurance requirements of sterile products and prevent product contamination.
  • Continuously improve laboratory practices by updating procedures and conducting training.
  • Support audits, validations, change control, product registration, and preparation of relevant reports.
  • Conduct laboratory investigations and implement appropriate corrective/preventive actions.
Requirements
  • Diploma/Degree in Life Science (Microbiology, Biology, Biotechnology, Pharmaceutical).
  • Scientifically, materials, products, and process evaluation or validation required by rules and regulations with relevant education and experience.
  • In-depth knowledge of cGMP, 21 CFR Part 211, EU MDD/MDR, and ISO 13485.