Job Summary
We are seeking a Quality Assurance Associate for Microbiology for managing daily Environmental monitoring operations in the Manufacturing facility as well as in microbiology laboratory. The qualified individual shall ensure that cleanrooms and classified manufacturing environments meet microbial and particulate cleanliness standards through the design, execution, and oversight of the Environmental Monitoring (EM) Program. This role supports cGMP compliance by providing data on environmental conditions by proactively identifying the contamination risks.
Roles & Responsibilities
Routine Monitoring Activities
You will be responsible to perform Viable (Settle plates, Active Air sampling, surface monitoring, contact plates and swab sampling) and non-viable particulate monitoring as per approved SOPs.
You will be responsible to perform Environmental Monitoring through LIMS software.
Monitor different cleanroom areas including ISO5/Grade A, Grade B, C and D.
You will be responsible to perform utilities monitoring (Compressed air, Nitrogen, CO2 and O2) for viable and Non-viable particulate load.
You will be responsible for personnel monitoring as well as gowning qualification of personnel who will be proposed to work in cleanrooms.
You will be responsible to perform water sampling (Raw water, treated water, Purified water, WFI and Pure steam) and to support the cross-functional department in area qualification /requalification.
You will be responsible to maintain and calibrate EM equipment (e.g. particle counters, air samplers) and related required accessories.
You will be responsible to train and qualify newly joined personnel in EM program and water sampling activity.
Data Management & Trending
Record and Review EM data accurately and in a timely manner.
Perform routine trend analysis of viable/non-viable data and report anomalies.
Participate in alert and action level excursions and support deviation management.
Prepare the Annual summary report for EM program along with determination of Alert and Action level based on the historical data.
Compliance and Documentation:
Adhere to cGMP, GDP and internal SOP requirements.
Prepare and review EM protocols, SOPs and investigation/ study reports.
Support in regulatory and internal audits by providing EM data and justifications/rationale for EM and water sampling plans.
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