Gmp Validation Consultant

2 weeks ago

Sydney, Australia pharmout pty ltd Full time

GMP Validation Consultant

PharmOut based in Melbourne Australia, 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 Sydney 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 locally, nationally and internationally. **All travel is by mutual agreement.**

**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
- Preparing validation reports
- 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 (or recover from one)

**Applicants should have**:

- Tertiary science or engineering qualifications
- At least 5 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

**What you will receive**:

- Competitive salary
- Part reimbursement of your relocation costs
- Great opportunity to work with many different companies
- Flexibility
- Be a part of a great team of experienced Validation Scientists and Engineers.

Schedule:

- Monday to Friday

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