Csv Consultant

9 hours ago


Burwood East, Australia PharmOut Pty Ltd Full time

**Are you an experienced computer systems validation professional?**

**Looking for an intellectual challenge in a dynamic environment?**

**Considered a career as a consultant?**

If you are looking for a career to challenge and excite you, come and work with **PharmOut.** PharmOut offers turn key design, engineering and compliance solutions.

Our core services include architecture, engineering, GMP compliance, validation and manufacturing design consulting to the health sciences sectors and the pharmaceutical, medical device, biologicals, blood and tissue manufacturing industries.

We need an experienced computer systems validation consultant to join our Melbourne team. As the largest employer of validation professionals in Australia, we offer you great development opportunities, training from world experts and the chance to work with the most prestigious companies both internationally and nationally.

We are looking for a computer system validation consultant who can work alone and will be:

- Using GAMP 5 methodology to risk assess systems
- Preparing and updating validation documents to help our customers meet their GMP compliance obligations
- Executing IQ, OQ and PQs
- Consult on Data Integrity

Applicants should have:

- Tertiary science or engineering qualifications
- At least 2-5 years' experience as computer systems validation professional.
- EU, TGA, PIC/S or FDA experience
- Demonstrable experience and proven skills in CSV/GAMP, technical writing, e.g. for process automation systems, ERP systems, lab equipment, facility management systems

Consulting or leadership experience would be highly regarded.

**Job Types**: Full-time, Permanent

**Salary**: $60,000.00 - $80,000.00 per year

Schedule:

- Monday to Friday

**Education**:

- Bachelor Degree (preferred)

**Experience**:

- Validation, QA or manufacturing professional: 5 years (preferred)

Work Authorisation:

- Australia (preferred)

Work Location: One location