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Microbiology Specialist

Apply Now Email Me Job ID R0004645 Date posted 09/27/2018 Location:Madrid, Spain

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Job Description

Purpose of the job:

Provide scientific and technical expertise in Microbiology methods, measurements and metrics as well as in aseptic processes

Major accountabilities

  • Supervise microbiological laboratory data and carry out trend analysis of environmental monitoring data
  • Propose and monitor implementation of appropriate corrective actions, assessment of alert levels  and of overall status of bioburden control of the facility and personnel working in the facility
  • Support process simulations, assess aseptic practices of personnel working in the manufacturing facility. 
  • Provide basic microbiology training and aseptic practices training to production personnel
  • Deliver technical support to the development and execution of microbiological methods such as Microbial Enumeration, Sterility in a barrier isolator, Endotoxin, Container Closure Integrity and non-routine microbiological assays and applicable GMPs & laboratory techniques.
  • Supervise maintenance/troubleshooting of laboratory equipment.
  • Author microbiology SOPs and scientific & technical protocols and reports. Communicate  results to QC Head and other functions as required
  • Perform laboratory investigations related to Deviations, OOS, and take part in change control processes.
  • Ensure accuracy & scientific soundness of Lab Data

Skills, experiences and qualifications required for the job:

Education:

  • BS/BA in Microbiology, Biological Sciences, or related field of study or a combination of education & experience.

Experience:

  • Required:
    • Minimum of 5 years of experience in a clinical or industrial/pharmaceutical microbiology laboratory or other highly GMP regulated environment
    • Expertise to support method development, method suitability and testing in support of the pharmaceutical industry.
    • Experience and expertise to write GMP documents
  • Desirable:
    • Industry experience as a microbiologist
    • Kinetic/Gel Endotoxin, bioburden, Sterility testing experience
    • Familiarity with Microorganism identification by DNA/RNA or related advanced techniques
    • Strong project management skills
  • Able to perform systematic problem solving
  • Tidy, neat and organized. Attention to detail
  • Must be able to work as part of a team but also have the confidence to work alone.
  • Good interpersonal skills
  • Flexible working attitude, open to changes for assuming new methodologies and activities.
  • General experience working with computers at user level, including MS Word, MS Power point and MS Excel.

Locations

Madrid, Spain

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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