Microbiology Lab Supervisor
bayer
Heredia, Heredia, CR
hace 4 días

Microbiology Lab Supervisor

YOUR TASKS AND RESPONSIBILITIES

  • Develop, transfer and implement testing methods for materials, device components, packaging materials and drug products according to approved and validated test methods.
  • Validate and implement the testing of environmental monitoring samples, bioburden, monitoring and analysis (water, compressed air), endotoxin test, among others.
  • Responsible of writing and reviewing qualifications and validation protocols and reports in collaboration with other team members.
  • Responsible of local SOPs elaboration.
  • Support for delivering Bayer B certificates along the project delivery roadmap in required quality and aligned timeline corresponding to microbiology laboratory.
  • Support to create Quality Master Data for QM Module in SAP.
  • In charge of microbiology laboratory, reagents and consumable inventory for daily operation, possibility of regency.
  • Responsible of daily operation planning of the microbiology laboratory.
  • Responsible for the reliability of the daily analyses and results, data integrity, OOS and CAPA analysis, root cause investigation.
  • Directly supervise microbiology laboratory personnel in daily operation.
  • Support the calibration and maintenance programs for the microbiology laboratory equipment.
  • Laboratory metrics elaboration.
  • Supports hire process, performs training of laboratory technicians (laboratory work).
  • WHO YOU ARE

  • University degree in Microbiology.
  • Excellent English language skills.
  • 5 years of experience in microbiology laboratories.
  • 2 years of experience with validation of analytical methods.
  • 2 years of experience supervising.
  • Statistical Techniques Knowledge.
  • Knowledge of QMS systems and subsystems.
  • Process Validation Knowledge.
  • Knowledge of laboratory systems.
  • Knowledge of environmental monitoring, critical systems monitoring and pharmaceutical / medical devices culture methods.
  • Knowledge of current Good Manufacturing Practices (cGMP’s).
  • Knowledge of ISO system (9001, 13485, 14644, 17025 is desirable)
  • Application Period : 07 / 06 / 2021 - 21 / 06 / 2021 Reference Code : 417309 Division : Pharmaceuticals

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