Csv Consultant

**Key Responsibilities**:

- Deliver consulting projects to support introduction, upgrade and maintenance of laboratory equipment with computerised system in the Life Sciences clients.
- Draft CQV and CSV deliverables such as URS, risk assessment, audit trail assessment, ERES assessment, IOPQ protocols, specifications and RTM.
- Execute CQ and CSV activities.
- Support equipment integration with other system such as network, manufacturing system and enterprise system.
- Support system configuration and CS activities such as backup and restore, access management, periodic review, etc.
- 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 at least 2 years in pharmaceutical, medical device or related environment.
- Have experience maintaining laboratory equipment with computerised system in pharmaceutical / medical device settings.
- Understand computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISPE GAMP5).
- Preferably with experience in change, incident and problem management.
- Preferably with technical knowledge of Windows OS, security system and backup system.
- Preferably with experience in configuring systems like LIMS, LES or ELN.

**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.

Pay: From $4,200.00 per month

Work Location: In person