Position Overview

We are looking for a dedicated and experienced QC Microbiologist to oversee microbiological testing and ensure compliance with quality standards and regulatory requirements. The role involves supervising the QC Microbiology laboratory, guiding lab personnel, and ensuring sterility assurance in both testing and manufacturing environments.

Key Responsibilities

• Supervise and perform microbiological testing including sterility, bioburden, endotoxin, and environmental monitoring.
• 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 and engineering to prevent contamination and maintain hygiene standards.
• Ensure availability and proper maintenance of lab supplies, equipment, and documentation.

Requirements

• Diploma or Degree in Life Sciences (Microbiology, Biology, Biotechnology, or Pharmaceutical Science).
• In-depth knowledge of cGMP, 21 CFR Part 211, EU MDD/MDR, and ISO 13485 standards.
• Minimum 3 years of experience in a microbiology or QC laboratory, preferably in a GMP-regulated environment.
• Strong understanding of sterility assurance and microbiological testing methods.
• Excellent leadership, communication, and problem-solving skills.
• Detail-oriented, organized, and able to manage multiple priorities effectively.