CQ Engineer / Consultant

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.