Equipment Qualification Specialist

3 days ago


Singapore Recruit Express Pte Ltd Full time

Job Summary:

We are seeking an experienced professional to join our team as an Equipment Qualification Specialist at Recruit Express Pte Ltd. This role involves developing and executing equipment qualification and validation plans and protocols that meet the required standards of quality and regulatory compliance.

Key Responsibilities:

  • To develop and execute equipment qualification and validation plans and protocols that meet the required standards of quality and regulatory compliance.
  • To conduct regular reviews of qualification and validation processes and documentation to ensure they are accurate, up-to-date and compliant with relevant regulations.
  • To maintain a comprehensive database of all equipment used in the organization, including records of calibration, maintenance and repair.
  • To work closely with internal stakeholders to schedule equipment activities that minimize disruption to operational activities.
  • To liaise with external suppliers to ensure timely procurement of equipment and services, including accessories and consumables.
  • To ensure adherence to regulatory requirements such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and other applicable guidelines.

Requirements:

  • Degree or Diploma in Life Sciences, Engineering, Information Systems or Computer Systems.
  • Experience in equipment commissioning, qualification and validation is highly desirable.
  • Background in GMP, biomedical or clinical research is also highly desirable.
  • Able to work in a cleanroom environment with specialized gowning procedures.
  • May be required to support pharmacy activities outside of regular working hours.


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