RAJKOT · FULLTIME
Microbiologist
Alkem MedTech
Rajkot · onsite · Posted 6d ago
Sourced from
₹6.0L - ₹10.0L PA6–10 yrsfulltimeRajkot
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Section · 01
About this role
- 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.
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Section · 02
Skills
Sterility TestingIn-process testingmicrobiological testingBioburden testing