Assistant Manager

7 days ago

Ahmedabad, Gujarat, India Aceto Pharma Full time ₹ 5,00,000 - ₹ 15,00,000 per year
  • 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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