Microbiology Specialist
Takeda Pharmaceutical Company Limited.
Madrid, Spain
hace 6 días

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 /

    Experience : Experience

    Required : Desirable

    Desirable

  • 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.
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