GMP Validation Consultant

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

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP knowledge

Validation experience

Technical writing

Client engagement

Education

Tertiary science or engineering qualifications

Job description

PharmOut is a leading international professional consultancy, specializing in servicing GMP industries. If you are looking for a career to challenge and excite you, PharmOut offers validation professionals varied and stimulating work across a diverse portfolio of clients.

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

We need experienced validation specialists to join our team based in Melbourne. 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 locally, nationally and internationally.

We are looking for validation consultants who will be:

• Preparing and updating validation documents to help our customers meet their 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 criticalityassessments
• Depending on experience, providing GMP compliance advice or helping a customer prepare for a GMP audit (or recover from one!)

Applicants should have:

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

The following attributes would be highly regarded:

• Consulting or leadership experience
• Experience in specialised GMP fields, such as aseptic or terminal sterilisation processes, non-sterile OSD manufacture, medicinal cannabis manufacture, cell therapies or technical transfer
• Computer systems validation and understanding of GAMP.
• Process validation and/or cleaning validation experience
• Ability to travel
• Long term Australian working rights (however, applicants currently in Australia on working tourist visas may be considered for contract roles)