CSV Consultant — GMP Compliance & Data Integrity

PharmOut; Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GAMP 5

IQ/OQ/PQ execution

Data Integrity

Education

Tertiary science or engineering qualifications

Job description

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.