CSV Consultant

PharmOut; Melbourne; Presencial; AUD 90 000 - 130 000; Tempo integral

Resumo da oferta

PharmOut, Melbourne, is seeking an experienced computer systems validation consultant to join our team. You will apply GAMP 5 methodology to risk assessments, and prepare validation documents to help clients meet GMP compliance.

You will execute IQ/OQ/PQ activities and provide guidance on Data Integrity across ERP, process automation, lab equipment and facility systems. Consulting or leadership experience is highly regarded.

Qualificações

• Tertiary science or engineering qualifications.
• 2–5 years' experience as computer systems validation professional.
• EU, TGA, PIC/S or FDA experience.
• Experience with CSV/GAMP and technical writing for automation, ERP, lab equipment or facilities systems.

Responsabilidades

• Using GAMP 5 methodology to risk assess systems.
• Preparing and updating validation documents to meet GMP compliance obligations.
• Executing IQ, OQ and PQs.
• Consult on Data Integrity.

Conhecimentos

GAMP 5

IQ/OQ/PQ execution

Data Integrity

Formação académica

Tertiary science or engineering qualifications

Descrição da oferta de emprego

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.