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1.0 - 5.0 years
0 Lacs
hyderabad, telangana
On-site
You will be responsible for conducting environmental monitoring in the In-Vitro Diagnostics production areas, Large Volume Parenterals production areas, and Microbiology Department. This includes filling out the related documentation for Environmental monitoring. Your role will involve analyzing the sterility test of finished/bulk/raw materials and documenting the results. Additionally, you will be responsible for performing the Bacterial endotoxin test on finished/bulk/raw materials. You will also analyze the Bioburden of bulk/raw materials and maintain detailed records of Temperature monitoring and relative Humidity in the analysis area log book. Water testing is a crucial part of the job which includes testing Raw water, purified water, and water For Injection (MLT and Pathogen testing) and documenting the results. You will also be responsible for conducting Microbial limit tests on raw materials and documenting the findings. Operating the steam sterilizer and vertical autoclave will be part of your duties, including filling out the related documentation for these operations. Another important task will be performing the Bacterial endotoxin test on water for injection. Additionally, you will need to conduct DOP on plates for all sections IVD, LVP, MBD and perform Gram staining tests while maintaining detailed records of these tests.,
Posted 4 days ago
0.0 - 4.0 years
0 Lacs
maharashtra
On-site
The QC Microbiologist I position involves performing various microbiological testing activities, such as water testing, environmental monitoring, media preparation, and growth promotion of media, under minimal supervision. In addition to conducting raw material testing, finished product testing, stability testing, antibiotic assay testing, gram staining, and microbial enumeration suitability testing, the role also includes antimicrobial effectiveness testing and other required microbial testing. The position requires maintaining quality and efficiency in all tasks performed. Responsibilities include routine water testing, media preparation, growth promotion of media, and environmental monitoring. The role also involves ensuring cleanliness and organization in shared laboratory areas, participating in stock inventory management, and conducting routine Microbial Examination Testing. Additionally, assisting with microbial suitability testing, antimicrobial effectiveness testing, antibiotic assay testing, gram staining, and other microbial testing is part of the job scope. Adherence to Environmental, Health and Safety policies and procedures is essential, along with flexibility to work overtime or weekends occasionally as needed. The ideal candidate should possess specialized knowledge of aseptic technique, environmental monitoring, and microbial examination methods. Familiarity with FDA, USP, ICH, cGMP, and cGLP requirements in a pharmaceutical quality control laboratory is necessary. Proficiency in LIMS, Microsoft Office Suite, and electronic data management systems is also required. Key qualifications include strong organizational skills, attention to detail, multitasking abilities, adaptability to changing priorities, ownership of tasks, proactive problem-solving approach, interpersonal and communication skills, and effective time management. The role may involve lifting/moving weights up to 10 lbs. and occasionally 25 lbs., handling hazardous and non-hazardous materials, and wearing Personal Protective Equipment as needed. Education requirements include a B.S. in microbiology, biology, or a related life science field. Candidates should have 0-4 years of related pharmaceutical microbiology experience and knowledge of autoclave usage, media preparation, aseptic technique, balance use, pH meter, environmental monitoring, and general plating practices. The ability to independently perform assigned tasks from start to finish without errors, including standard, sample, and reagent preparation through data processing and submission, is essential. This is a full-time position based in USA-650 Cathill Road, Sellersville, PA, 18960, US, with job identification 90441128 in the Quality Control category.,
Posted 5 days ago
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