CQ Engineer

6 days ago

West Region, Singapore 8bae7fce-32af-461b-b685-505b7ab5a50f Full time $6,000 - $12,000 per year
Key Responsibilities:
  • Deliver consulting projects in the process-related areas including but not limited to Equipment Qualification, Computer System Validation (CSV) and other qualification and validation discipline.
  • Draft CQ deliverables such as URS, risk assessment, data integrity related assessment and qualification protocols.
  • Execute CQ protocols such as temperature mapping and CSV testing / verification.
  • Support business and service development initiated by the management of ORKA.
Requirements:
  • Hold Bachelor's degree in Life Sciences, Engineering or related field.
  • Have worked for at least 2 years in pharmaceutical, medical device or related environment.
  • Fresh graduates with internship in pharmaceutical or medical device industry and some relevant experience may apply for a Junior role.
  • Have good understanding of regulatory requirements and relevant industry best practice.
  • Preferably with hands-on experience with Kaye Validator or Ellab temperature mapping system.
  • Preferably with understanding of ASTM E2500 practice.
  • Enjoy working as a Consultant.
Why Join ORKA:
  • Work that Matters: Support clients bringing innovative and life saving solutions to the population.
  • Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
  • Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
  • Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

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