To prepare, sterilize and dispense media and carry outgrowth promotion test of the same.
To perform sampling and analysis of finished product for Microbiological tests.
To perform sampling and analysis of water for Microbiological and Chemical tests.
To monitor cleaning and waste disposal of the Microbiology laboratory.
To perform Environmental monitoring of Controlled areas in Microbiology laboratory and in the manufacturing area.
To maintain microbial cultures.
To perform internal calibration of instruments.
To review instruments/equipment's annual maintenance contract and coordinate with external party for validation and calibration activities.
To prepare and review analytical data.
To maintain inventory of instrument’s spares, apparatus, media, and chemicals.
To follow up with engineering department related to electrical, instrument and general maintenance.
To Assist Manager - Quality control in representing Quality Control Department to all external audits from Takeda, Customers, ISO 14001, OHSAS 18001 & regulatory authorities.
Ensure environment protection by controlling Air / Water / Soil pollution from analytical activities.
To implement Lab excellence/ agile projects for overall department excellence.
Accountable for safe operation of the facility, their own safety and safety of other coworkers
Hands on experience of instrumentation and analysis in Microbiology
Aware of Microbiology functioning
Aware of Gxp Requirement in QC Laboratory.
Qualifications
Education - MSc. Microbiology from reputed institute
Experience - 3 to 5 Yrs. (API - Pharma Industry)
Good knowledge of API Plant QC - Microbiology Section
Aware of Good Manufacturing Practices and QMS Documentation