Are you an experienced computer systems validation professional?
Looking for an intellectual challenge in a agile 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.
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