Assistant Manager - Microbiology
Aceto Pharma (India) Private Ltd.
- Ahmedabad, Gujarat
- Rs. 10,00,000 per year
- Permanent
- Full-time
- To maintain the microbiology lab in accordance with GMP system.
- To raise requisition for resources relevant to microbiology lab.
- To perform efficient/reliable microbial testing in accordance with USP/USP-NF/EP/JP or customer guidelines.
- Testing may include microbial parameters in water, product contact surface environmental monitoring,
- viable air monitoring, and Microbial Limits Tests, Pathogens as well as BET test in raw materials and finished goods
- To check, review and approval of microbiological results.
- To schedule daily tasks in an organized and efficient manner with minimum directive.
- To review, revise and/or write microbiology test methods and prepare all SOPs related to micro department.
- To prepare and perform microbiological test method validation protocols and summary reports like,
- Gowning validation, Disinfectant validation withhold time study, MLT method validation, BET method validation etc.
- To prepare and perform microbiological validation protocols, IQ/OQ/ PQ, and summary reports for all instruments like Autoclave, Incubator, and LAF etc.
- To lead investigations involving microbiological out of specification results.
- To train new microbiologists on SOPs and test methods and serve as a role model.
- To ensure calibration and maintain microbiology lab equipment.
- Responsible for a clean, hygienic and safe working environment
- To impart training as per training calendar.
- Involvement in Audit and NC compliance with their record.
- Awareness and get intervention through reliable sources for any changes / revision in microbiology related documents / MOA.
- Responsible for resource requirement indent.
- To respond to customer query and documentation.
- Responsible for aqua water testing kit.
- Responsible for new product development of Probiotics preparation in large scale work with outside agency.
- Comply with applicable environmental, health and safety laws and regulations, company policy, and accepted safe work practices.
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