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Regulatory Compliance Professional

1 week ago

Singapore Recruit Express Pte Ltd Full time

Role Overview:

We are currently seeking a Regulatory Compliance Professional to join our team at Recruit Express Pte Ltd. The successful candidate will be responsible for ensuring that equipment qualification and validation plans and protocols meet the required standards of quality and regulatory compliance.

Key Accountabilities:

  • To develop and implement equipment qualification and validation plans and protocols that meet the required standards of quality and regulatory compliance.
  • To conduct regular audits of qualification and validation processes and documentation to ensure accuracy, up-dateness and compliance with relevant regulations.
  • To create and maintain a comprehensive inventory of equipment used in the organization, including records of calibration, maintenance and repair.
  • To collaborate with internal stakeholders to schedule equipment-related tasks that minimize disruptions to operations.
  • To communicate with external suppliers to secure timely deliveries of equipment and services, including accessories and consumables.
  • To ensure compliance with regulatory requirements such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and other applicable guidelines.

Necessary Qualifications:

  • Degree or Diploma in a relevant field such as Life Sciences, Engineering, Information Systems or Computer Systems.
  • Desirable experience in equipment commissioning, qualification and validation.
  • Background in GMP, biomedical or clinical research is highly desirable.
  • Able to work in a controlled environment with strict gowning procedures.
  • May be required to assist with pharmacy-related duties outside regular working hours.