GMP Validation Specialist - Compliance & Audits

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

Resumo da oferta

PharmOut is seeking experienced validation consultants to join our Melbourne team. You will work with GMP-regulated clients across EMA, US FDA, TGA and PIC/S to ensure compliant manufacturing processes.

You will prepare and update validation documents, develop plans and specifications, execute qualification protocols, and document risk assessments. Depending on experience, you may advise GMP compliance or assist audits.

Qualificações

• Tertiary science or engineering qualifications.
• At least 3 years' experience in validation, or as a QA or manufacturing professional with exposure to validation concepts.
• Previous experience in GMP manufacturing environments regulated by EMA, TGA, PIC/S or US FDA.
• Proven skills in GMP technical writing, e.g. SOPs and related QMS documentation, validation plans, protocols and reports.

Responsabilidades

• Preparing and updating validation documents to help customers meet GMP compliance obligations.
• Working with clients to develop plans and specifications.
• Executing qualification and validation protocols.
• Participating in and documenting validation and compliance risk and criticality assessments.
• Depending on experience, providing GMP compliance advice or helping a customer prepare for a GMP audit.

Conhecimentos

GMP knowledge

Validation experience

Technical writing

Client engagement

Formação académica

Tertiary science or engineering qualifications

Descrição da oferta de emprego

PharmOut is seeking experienced validation consultants to join our Melbourne team. You will work with GMP-regulated clients across EMA, US FDA, TGA and PIC/S to ensure compliant manufacturing processes.

You will prepare and update validation documents, develop plans and specifications, execute qualification protocols, and document risk assessments. Depending on experience, you may advise GMP compliance or assist audits.