Director, Microbiology - Pharmaceuticals

Company: Cameron Craig Group
Location: Monroe
Posted on: January 11, 2022

Job Description:

The Director, Microbiology manages a team of microbiologists to oversee all microbiological quality aspects of pharmaceutical manufacturing (injectable and OSD), including, but not limited to: sterility, environmental monitoring of warehouse, dispensing area, manufacturing, packaging, and quality control. Implementation of Entry/Exit and gowning procedure while entering the classified areas. Disinfection Validation study for different Disinfectants. Isolation and identification of different Environmental isolates. Preparation and implementation of the Standard Operating Procedures and Standard Testing Procedures written to microbiology Maintenance of different cultures by sub culturing passages from the original cultures. (Seed-Lot Culture Maintenance Technique). Microbiological limit test for various pharmaceutical preparations. Validation and verification of microbiological methods.

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• Ensuring compliance to system and procedures in the department and documentation.
  
• Preparation of the Microbiology Laboratory for internal and external audits.
  
• Ensure online documentation in microbiology laboratory.
  
• Ensure compliance, revision and updates to SOPs as per Good Microbiology Laboratory practices and pharmacopeia.
  
• Updating specification and standard test procedures of the microbiology section.
  
• Work distribution to subordinates of Microbiology Section.
  
• Procure consumables and other materials.
  
• Ensure annual maintenance contact renewal (if any), calibration of laboratory instruments.
  
• Prepare risk assessment in for various processes in microbiology laboratory.
  
• Procurement and qualification of new equipment required in microbiology laboratory.
  
• Ensure timely sampling, analysis and release of environmental, water samples.
  
• Ensure timely analysis and release of Raw material, finish products and packing materials.
  
• Ensure 100% training of subordinates in microbiology department as per the job requirement.
  
• Review of change control, incidents, protocols and deviation of other departments related to microbiology.
  
• Ensure requalification and calibration of instruments in micro lab as per the schedule.
  
• Response preparation for internal and external audit observation. Implementation of CAPA in micro lab.
  
• Review of regulatory audit observations at other sites and ensure compliance in microbiology department of the site.
  
• To interact with site QA and inform about failures/ OOS / OOT / incident / Non compliances.
  
• Responsible for overall management of Microbiology department
  
• Responsible for coordination with Production / R&D/QA/QC for various activities related to microbiology
  
• Interact with different departments in case of OOT, OOAC, OOAL and OOS observations related to microbiology
  
• Train Responsible for overall management of Microbiology department
  
• Responsible for coordination with Production / R&D/QA/QC for various activities related to microbiology
  
• Interact with different departments in case of OOT, OOAC, OOAL and OOS observations related to microbiology
  
• Train and implement cGMP practices related to microbiology at all the manufacturing and related departments and implement cGMP practices related to microbiology at all the manufacturing and related departments
  
  Education: Master's degree in Microbiology or equivalent experience
  
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  • Experience: 10 - 15 years in the field of Pharmaceutical (formulation facility).
    Background of functions of Microbiology.
    
  • Experience of working with Injectable facility will be an added advantage.
    
    Knowledge and Skills:
    
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    • Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquaintance with QMS, well versed with Change control/deviations and market complaint management system.
      
      
      
      

Keywords: Cameron Craig Group, Rock Hill , Director, Microbiology - Pharmaceuticals, Executive , Monroe, South Carolina