CQV Consultant

1 week ago

Singapore ORKA CONSULTING PARTNERS PTE. LTD. Full time $60,000 - $120,000 per year
Short Job Description:

The CQV Consultant / Engineer delivers commissioning and qualification services for equipment such as temperature controlled equipment / temperature controlled unit, warehouse and process equipment. The Consultant / Engineer ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.

Key Responsibilities:
  • Deliver consulting projects to support introduction and upgrade of manufacturing, manufacturing support and laboratory equipment in the Life Sciences clients.
  • Draft equipment qualification deliverables such as URS, risk assessment, data integrity related assessment, CQ (IQ/OQ) protocols, specifications and RTM.
  • Execute equipment qualification activities.
  • Monitor and support equipment vendor in conducting equipment CQ, calibration and maintenance.
  • Perform document control activities including change management.
    Draft, revise and review SOPs, forms and related operational and maintenance documents.
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 working experience in manufacturing or laboratory operations and equipment.
  • Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11).
  • Preferably with experience performing mapping of temperature controlled system such as incubator, fridge, freezer, autoclave or warehouse.
  • Preferably familiar with process tank, FIT machine, ViCell, spectrophotometer, pH / conductivity meter, osmometer, etc.
    Preferably with experience in using VLMS like Kneat.
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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