To ensure receipt, registration and upkeep of samples in the laboratory.
To complete review of microbiological testing reports related to (but not limited to) raw materials, finished products, stability
study samples and Hold Time Study samples, water testing, microbial method validations and environmental monitoring.
To ensure timely review and release of the report and submission to the respective section.
Maintain GLP compliance, inspection readiness and best microbiology practices.
To maintain laboratory workplace, instruments and equipment.
Review of records related to microbial media preparation, sterilization, GPT, media reconciliation garment sterilization.
Review of documents related to Temp and RH, Pressure differentials, UV, incubator cleaning and temperature data and area
cleaning and sanitization and fumigation.Review, locking and usage decision of water reports entered in SAP.
To ensure timely completion of laboratory instrument/ equipment’s and review of electronic records.
To ensure timely disposition of balance analytical samples and expired media.
To ensure readiness of water and Environmental monitoring trend and Summary report and Summary report of compressed air.
Reporting and investigation of Deviations, Out of Action/AIert Limits and LIR in the laboratory.
To ensure timely/ periodic revision of Quality Control Procedures, Standard Test Procedures, Specifications, Standard operating procedures and Glorya related activities.
To support in facility qualification in coordination with the engineering and manufacturing for new area, area modification, water system, compressed air system for Microbiology section related activities.
Timely closeout and effective implementation of CAPA assigned by different sections and identified during investigation of quality documents.To ensure compliance to the policy and procedures requirements on data integrity.