Cqv Consultant

2 days ago

Singapore ORKA CONSULTING PARTNERS PTE. LTD. Full time

**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.
- 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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