QC Microbiology Lead - Sterility & Compliance

Opto-Pharm Pte Ltd; Singapore; Vor Ort; SGD 60.000 - 90.000; Vollzeit

Zusammenfassung

Opto-Pharm Pte Ltd is seeking a dedicated QC Microbiologist to oversee microbiological testing and sterility assurance in our GMP-regulated environment. You will lead the QC Microbiology laboratory, guide lab personnel, and ensure compliance with quality standards and regulatory requirements.

The role requires hands-on testing experience, strong leadership, and collaboration with production and engineering to prevent contamination and maintain lab documentation.

Qualifikationen

• Diploma or Degree in Life Sciences with a focus on microbiology.
• Knowledge of cGMP, 21 CFR Part 211, EU MDD/MDR, ISO 13485.
• Minimum 3 years in microbiology/QC lab, GMP preferred.

Aufgaben

• Supervise and perform microbiological testing (sterility, bioburden, endotoxin, EM).
• Train lab technicians in testing and good lab practices.
• Oversee environmental monitoring and sterility assurance controls.
• Ensure compliance with cGMP, ISO 13485, and USP/ISO standards.
• Conduct investigations and implement CAPA.
• Support audits, validation, change control, and product registration activities.
• Review and update SOPs to meet regulatory requirements.
• Collaborate with production and engineering to prevent contamination.
• Maintain availability of lab supplies, equipment, and documentation.

Kenntnisse

Leadership

Communication

Problem-solving

Detail-oriented

Organizational skills

Ausbildung

Diploma or Degree in Life Sciences

Jobbeschreibung

Opto-Pharm Pte Ltd is seeking a dedicated QC Microbiologist to oversee microbiological testing and sterility assurance in our GMP-regulated environment. You will lead the QC Microbiology laboratory, guide lab personnel, and ensure compliance with quality standards and regulatory requirements.

The role requires hands-on testing experience, strong leadership, and collaboration with production and engineering to prevent contamination and maintain lab documentation.