Microbiologist

Possess understanding and hands-on experience in performing sterility testing, bioburden testing, and microbiological testing.

· Support EO (Ethylene Oxide) Sterilization validation activities including IQ/OQ/PQ of machinery and equipment, routine monitoring, data review & interpretation, suggestions for improvement, problem solving and troubleshooting, understanding of operation and limitations of EO Sterilizer.

· Understanding of Gamma sterilization process and result interpretation.

· Possess hands-on experience in developing SOPs and Work Method Statements in compliance with requirements of ISO 13485.

· Preparing culture media, inoculating cultures, and maintaining appropriate laboratory conditions for microbial growth

· Documenting test results accurately and preparing detailed laboratory reports.

· Following and adhering to standard operating procedures (SOPs) and quality assurance protocols to ensure consistent and reliable results

· Maintaining laboratory equipment, including incubators, autoclaves, microscopes, and other microbiological instruments

· Assisting in the development and validation of new microbiological testing methods

· Participating in quality control and quality assurance activities including proficiency testing and internal audits.

· Manage and conduct microbiology section activity on daily routine analysis.

· Create, revise and review protocols, supporting microbiological data and reports associated with method validation, testing and release of starting materials, intermediates, finished products.

· Monitor, execute and analyse data of environmental monitoring.

· Develop, revise and review SOPs, qualification/validation protocols and reports.

· Execution of the product quality review process.

· Conduct the corrective action and preventive action system.