Lead Microbiologist – GMP Sterility & QC Lab

AIM RECRUIT CONSULTANCY PTE. LIMITED

Singapore

On-site

SGD 60,000 - 90,000

Full time

3 days ago

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Job summary

AIM RECRUIT CONSULTANCY PTE. LIMITED is seeking a Microsbiologist to join our life sciences team in Tuas, Singapore.

You will perform microbiological testing, including sterility, bioburden, endotoxin, and environmental monitoring, ensuring adherence to GMP and ISO standards. You will supervise lab technicians, maintain CAPA, support audits and validations, and update SOPs to meet regulatory requirements while collaborating with production and engineering to prevent contamination and maintain

Qualifications

Diploma/Degree in Life Sciences/Pharmaceutical with 3 years in a microbiology/QC laboratory.
In-depth knowledge of cGMP, 21 CFR Part 211, EU MDD/MDR, and ISO 13485 standards.
Strong understanding of sterility assurance and microbiological testing methods.

Responsibilities

Perform microbiological testing including sterility, bioburden, endotoxin & environmental monitoring.
Supervise, guide and train lab technicians on microbiological testing and good lab practices.
Oversee environmental monitoring and ensure effective sterility assurance controls.
Ensure compliance with cGMP, ISO 13485, and relevant USP/ISO standards.
Conduct laboratory investigations and implement corrective/preventive actions (CAPA).
Support audits, validation, change control, and product registration activities.
Review and update SOPs to align with regulatory requirements.
Collaborate with production & engineering to prevent contamination and maintain hygiene standards.
Ensure availability and proper maintenance of lab supplies, equipment, and documentation.