Sr. Manager

7 days ago

Ahmadnagar, Maharashtra, India sun pharmaceutical ltd. Full time
Job Description

Job Title:

Manager / Sr.Manager Micro Lead

Job Grade:

G10 / G9B

Function:

Global API Business

Sub-function: Managers Job Title: Skip Level Managers 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 vendor.
  • 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 concerns in time and contribute in troubleshooting.
  • To ensure and review all logbooks and registers are maintained online 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 during day-to-day activities.
  • Responsible for carrying out any other responsibilities assigned 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.
Travel Estimate Job Requirements Educational Qualification

M.Sc (Microbiology)

Specific Certification Skills Experience

15 to 18 Yrs

Locations - Ahilyanagar - Quality Control

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