Assistant, Pithampur Quality

Strategy & Planning

Functional

Core

• Plan for sampling & testing of raw materials, finished products, in-process samples, swabs, air and water, stability samples as per the given QC plans and specifications for microbiological testing and monitoring
• Maintaining daily records of various microbiological instruments and areas as per Standard test procedure.
• Maintaining logbook for autoclave sterilization and autoclave validation using biological indicators as per procedure
• Additional gelatin testing as per inhouse Testing procedure.
• Other microbiological testing including Compressed air, Greaser shells, Lubrication oil, Talc, Filter bags etc.
• Sampling and testing of primary packing material as per defined procedure.
• Sampling and testing of employee swab as per defined procedure.
• Analysis and reporting (including SAP entry and COA)
• Investigation and CAPA for microbiological Internal & External failures
• Surveillance for microbiology compliance
• Preparation of microbiological trends for air and water as per define procedure and frequency
• GLP and documentation as per ALOCA, laboratory facility maintenance
• Isolation and identification of isolates and maintenance of standard culture Operations of Vitek 2 instrument to fulfill requirement of all other business units.
• Vitik
• Growth Promotion test to be performed on every incoming lot of media.
• Sampling of RM, Finished product, Environmental monitoring.
• Calibration and validation (testing support, laboratory equipment qualification, method validation, disinfectant validation).
• GLP and documentation with ALCOA+ approach, & laboratory facility maintenance.
• participate
• Preparation of Microbial SOPs and STPs.
• Release of raw material (in absence of QC Section in charge).

1. Key Result Areas

2. Key Interfaces