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1.0 - 2.0 years
2 - 3 Lacs
Ahmedabad
Work from Office
Role & responsibilities Assisted senior microbiologists in performing various microbiological tests, including sterility testing, bioburden testing, and environmental monitoring. Maintained accurate records and ensured compliance with GMP and SOP guidelines. Prepared and sterilized microbiological media and reagents. Performed routine equipment maintenance and calibration. Contributed to the development and improvement of laboratory procedures. Preferred candidate profile
Posted 1 month ago
- 1 years
2 - 6 Lacs
Gujarat
Work from Office
Job Summary: We are seeking a motivated and skilled QC Microbiologist to join our Quality Control team. The successful candidate will be responsible for performing microbiological testing on raw materials, in-process samples, finished products, water systems, and environmental monitoring to ensure compliance with GMP and regulatory standards. Key Responsibilities: Conduct microbiological testing of raw materials, in-process samples, finished products, and stability samples. Perform environmental monitoring of manufacturing areas including viable and non-viable particle counts, surface monitoring, and air sampling. Carry out water analysis (e.g., Total Microbial Count, Endotoxin, TOC). Execute Sterility testing, Microbial Limit Tests (MLT), Endotoxin testing (LAL method), and Growth Promotion Tests (GPT). Maintain proper documentation of all microbiological activities in compliance with cGMP and GLP. Participate in method validation, media preparation, and equipment qualification. Investigate microbiological deviations, OOS/OOT results, and support implementation of CAPA. Ensure calibration and maintenance of all microbiological instruments (e.g., incubators, autoclaves, particle counters). Support internal and external audits by regulatory authorities. Comply with all lab safety protocols and procedures. Exp.- Fresher or 1 year of experience in a pharmaceutical microbiology lab. Location-Por GIDC, Gujarat
Posted 3 months ago
3.0 - 5.0 years
5 - 10 Lacs
rajkot
Work from Office
Alkem MedTech Pvt Ltd is a wholly owned subsidiary of Alkem Laboratories Ltd, which is the 5th largest listed Pharmaceutical company in terms of market share. As the first MedTech venture of Alkem Labs, Alkem MedTech is dedicated to advancing precision, high-risk, and implantable medical devices along with their accessories. MedTech is a strategic priority for Alkem Labs, representing a significant growth avenue. We are beginning our MedTech journey by focusing on Musculoskeletal solutions and have plans to expand into multiple segments, establishing a robust, multi-faceted MedTech company in the near future. Alkem MedTech will be manufacturing in India, aligning with the vision of the Government of India to boost domestic production and innovation in the medical technology sector. We are looking for passionate and innovative talents to join our pioneering team. If you are excited about shaping the future of medical technology and want to be part of a transformative journey, Alkem MedTech is the place for you. Why Join Us? Innovation-Driven Environment : Work on cutting-edge technologies in precision and implantable medical devices. Growth Opportunities : Be part of a strategic growth initiative for one of the leading pharmaceutical companies and be part of creating a legacy. Collaborative Culture : Engage with a team of dedicated professionals committed to making a difference in healthcare. Impactful Work : Contribute to life-changing medical solutions in the Musculoskeletal segment and beyond. Manufacturing in India : Support the vision of the Government of India by contributing to domestic production and innovation in the MedTech sector. Join us at Alkem MedTech and help shape the future of healthcare technology. Purpose of the role: The Microbiologist is responsible for ensuring the sterility of orthopedic knee and hip joint implants, monitoring microbiological processes, conducting microbiological testing, and ensuring compliance with relevant standards and regulations. This role involves conducting environmental monitoring, sterilization validation, and contamination control to ensure product safety and quality. 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.
Posted Date not available
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