Laboratories Lead
Bayer
Heredia, Costa Rica
hace 5 días

YOUR TASKS AND RESPONSIBILITIES

  • Responsible to develop, transfer and implement testing processes of starting materials, device components, packaging materials and drug products according to approved and validated test methods.
  • Responsible to develop, transfer and implement testing of environmental monitoring samples, bioburden, monitoring and analysis (water, compressed air), endotoxins tests, among others as needed.
  • Responsible for the reliability of the analyses and results.
  • Responsible to define, acquire and validate the laboratory equipment as well as ensuring maintenance and calibration activities.
  • Lead development and validation of test methods and transfer of test methods. Ensure readiness for Operations based on project timeline.
  • Responsible to lead sterilization validation processes, qualify suppliers to perform related sterilization quality tests and perform sterilization requalification activities as required.
  • Provide design guidance and support of the laboratory’s areas.
  • Responsible to create Quality Master Data for QM Module in SAP.
  • Responsible for delivering Bayer B certificates along the project delivery roadmap in required quality and aligned timeline corresponding to Laboratories.
  • Write, review and / or approve qualification protocols and reports in collaboration with other team members.
  • Responsible to establish and monitor the budget of the laboratories according the project need. Take necessary actions, if required.
  • Responsible to implement short term, mid-term and long term capacity planning.
  • Responsible to hire, train, guide and lead chemists, lab technicians, technical assistants (laboratory work).
  • Provide appropriate initial and continuing training for the laboratory personnel.
  • Team member to track progress and escalate to Quality lead, if needed.
  • Performs other duties and tasks as required to support the project development, leading to and through operational start-up and sustainable commercial operation.
  • WHO YOU ARE

  • BA / BS required in (Chemical Engineering, Chemistry, Microbiologist, Biotechnologist).
  • 5 years of experience in microbiological laboratories.
  • 2 years of leadership experience.
  • Advanced English level, both written and spoken.
  • Experience on chemical and physical labs is a plus.
  • Knowledge in sterilization process and validation.
  • Statistical Techniques Knowledge.
  • Knowledge of QMS systems and subsystems utilized to manage and regulate work and workflow within pharma or medical device industry.
  • Process Validation Knowledge.
  • Knowledge of laboratory systems / systems management.
  • Knowledge on analytical method validation process.
  • Knowledge in technology transfer.
  • Proficient with Microsoft Office tools.
  • Demonstrated advanced problem-solving abilities.
  • Reportar esta oferta
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Inscribirse
    Mi Correo Electrónico
    Al hacer clic en la opción "Continuar", doy mi consentimiento para que neuvoo procese mis datos de conformidad con lo establecido en su Política de privacidad . Puedo darme de baja o retirar mi autorización en cualquier momento.
    Continuar
    Formulario de postulación