Sr Manager - Micro Lead

Job Title

Manager / Sr.Manager – Micro Lead

Job Grade

G10 / G9B

Function

Global API Business

Sub-function

Manager’s Job Title:

Skip Level Manager’s Title

Function Head Title:

Location:

Ahmednagar

No. of Direct Reports (if any)

Areas of Responsibility

• To plan, review and monitor overall activities in Microbiology and lead the department.
• Co-ordination with other departments for priorities and provide the timely support/testing to avoid delay due to analysis.
• Review of all departmental related documents and review results in LIMS system in microbiology section. Ensure all documents are complete in time.
• To review the lysate sensitivity test, Bacterial endotoxin test of WFI and API products.
• To check method validation of bacterial endotoxin test and microbial quality of products.
• To procure, receipt, storage, maintenance, its use and reconciliation of biological indicator, media, reagents standard cultures and bioball etc.
• To ensure and check calibration and Operation of TOC analyzer Execute breakdown (If any) in consultation with vender.
• To ensure environmental monitoring activities performed as per schedule and to check the environmental monitoring reports.
• To review qualification, Calibration of all instruments in microbiology laboratory as per SOP/Schedule.
• To participate in investigation and to review of deviations/OOS/OOT/OOC/Lab Event / & review of SOPs as per revision date in micro section online in track wise system.
• To highlight observations, rejection / failure, quality related concern in time and contribute in troubleshooting
• To ensure and review all logbooks and registers are maintained on line and available at designated place.
• Preparation and review of GMP documents related to activities.
• To review and ensure fumigation activity and its verification as per SOP/Guidelines.
• To prepare / review trends for water and environment monitoring, Summary report of water and environment monitoring.
• Responsible to follow online good documentation practices for data recording and monitoring.
• To ensure and review validation of autoclave, Dry heat sterilizer (DHS), Incubators, Laminar Air flow, HVAC.
• To ensure and review preparation of reagents and volumetric solution and its standardization as per specification / SOP.
• To ensure and review inventory and stock record of media/reagents/culture/lysate/CSE/LRW.
• To ensure to follow the GLP as per current practice in the laboratory.
• To ensure safety and use of personnel protective equipment’s during day to day activities
• Responsible for carrying out any other responsibilities assign from time to time orally or in writing by Quality head, however related training imparted to concerns.
• To support for review and compliance activity in quality function and to support for any time readiness as well as enhancement of system and practices.
• To Coordinate with corporate functions with respect to microbiology activity.