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Urgent! CQV Engineer Job Opening In Outram Park – Now Hiring ORKA CONSULTING PARTNERS PTE. LTD.



Job description

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 / IOQ 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.

Job Type: Full-time

Pay: From $4,200.00 per month

Work Location: In person


Required Skill Profession

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    Unlock Your CQV Engineer Potential: Insight & Career Growth Guide


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