- 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.
Role: Quality Assurance - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Quality Assurance, Employment Type: Full Time, Permanent Role Category: Quality Assurance - Other Education PG: MS/M.Sc(Science) in Any Specialization read more
Key Skills Skills highlighted with ‘‘ are preferred keyskills Bioburden TestingIn-Process TestingMicrobiological TestingSterility Testing