Microbiologist

Alkem MedTech; Rajkot; On-site; INR 420,000 - 660,000; Full time

Job summary

Alkem MedTech in Rajkot is seeking a microbiology specialist to perform comprehensive testing across raw materials, in-process samples, and finished products in accordance with GMP and ISO standards. The role includes environmental monitoring, sterilization validation, and CAPA investigations to uphold quality and safety.

You will prepare detailed reports, support audits, and contribute to SOPs and training, ensuring compliance with FDA, ISO 13485, and EU MDR.

Responsibilities

• Perform microbiological testing of raw materials, in-process samples, finished products, and environmental samples per GMP/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 monitor routine sterilization cycles.
• Investigate microbial contamination events and implement CAPA.
• Maintain microbiological laboratory instruments, ensuring calibration, validation, and maintenance.
• Prepare detailed reports on microbiological findings, test results, and environmental monitoring data.
• Ensure regulatory compliance including FDA, ISO 13485, and EU MDR.
• Provide microbiological support during audits and inspections by regulatory bodies.
• Develop and review microbiological SOPs and test protocols.
• Train and mentor junior staff on microbiological procedures and aseptic techniques.

Job description

• Perform microbiological testing of raw materials, in-process samples, finished products, and environmental samples in accordance with GMP (Good 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.