Lead - Lab Microbiologist, ACG Capsules (Quality)

Qualification Required and Experience

Qualification - MSC (Microbiology & Biotechnology)

Exp - 3 to 5 Years

Primary Responsibilities

• 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 customer specifications for microbiological testing and monitoring
• Sampling and Environmental monitoring
• Analysis and reporting (including SAP entry and COA)
• Trending, Investigation and CAPA for microbiological failures
• Surveillance for microbiology compliance
• Calibration and validation (testing support, laboratory equipment qualification, method validation, disinfectant validation)
• GLP and documentation, laboratory facility maintenance
• Release of raw material (in absence of QC Head)
• Preparation of Microbial SOPs and STPs
• Participate in various quality improvement programs and organizational initiatives
• Isolation and identification of isolates and maintenance of standard culture

Key Result Areas

1. Perform complete Microbiological testing
2. Lay down systems and practices for ensuring FTR, microbiological quality of products

In order to ensure production and delivery of microbial compliant capsules

Key Interfaces

• Timely completion and reporting of all Microbiological testing to enhance smooth production activity
• No external failures for microbiology
• No non-compliance in internal and external audits

Improvement in microbiology trends