Microbiology Lab Lead — GMP/ISO & QA Expert

PT Medisafe Technologies

Sumatera Utara

On-site

IDR 89,280,000 - 167,400,000

Full time

5 days ago

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Job summary

PT Medisafe Technologies is seeking a Microbiologist to oversee daily microbiology laboratory operations, environmental monitoring, and product testing to ensure ISO 13485, ISO 11737, GLP and GMP compliance. You will lead method verifications, instrument qualifications, and investigations while supporting new lab facilities.

The role requires a Bachelor’s or Diploma in Microbiology or related field, 4+ years of industrial microbiology experience, and domicile in Medan.

Qualifications

Bachelor's or diploma in microbiology/biotechnology or related field.
Minimum 4 years of industrial microbiology experience preferred.
Hands-on bioburden and sterility testing experience.
Strong GMP/GLP and ISO 13485/ISO 11737 knowledge.
Excellent documentation and reporting skills.

Responsibilities

Oversee daily microbiology laboratory operations.
Conduct product testing procedures.
Ensure compliance with ISO 13485, ISO 11737, GLP and GMP.
Perform bioburden, sterility testing and sampling.
Lead method verifications and instrument qualifications.
Conduct quality investigations.
Set up new lab facilities.
Act as primary technical expert for microbiological quality across Production, Engineering, and QA teams.