- Perform microbiological testing of raw materials, in-process samples, finished products, and environmental samples in accordance with GMP (Valuable Manufacturing Practices) and ISO standards.

- Conduct sterility testing, endotoxin testing, and bioburden testing of implants and related materials.

- Monitor and maintain environmental controls in cleanrooms, including air, surface, and personnel monitoring.

- Validate sterilization processes (e.g., Ethylene Oxide, Gamma Radiation) and perform routine sterilization cycle monitoring.

- Investigate microbial contamination events and implement corrective and preventive actions (CAPA).

- Maintain microbiological laboratory instruments, ensuring calibration, validation, and proper maintenance.

- Prepare detailed reports on microbiological findings, test results, and environmental monitoring data.

- Ensure compliance with regulatory requirements including FDA, ISO 13485, and EU MDR.

- Provide microbiological support during audits and inspections by regulatory bodies.

- Develop and review microbiological standard operating procedures (SOPs) and test protocols.

- Train and mentor junior staff on microbiological procedures and aseptic techniques.

📌 Microbiologist (Rajkot)
🏢 Alkem MedTech
📍 Rajkot