Quality Assurance and CSV Associate – Pharmaceutical Industry

JAG Process Solutions; Melbourne; Hybrid; AUD 70,000 - 90,000; Full time

Benefits offered by this job

Extensive In-House Training

Unique Project Opportunities

Career Progression

Cutting-Edge Technologies

Innovation-Driven Culture

Valued Contribution

Employee Care

Flexible Working Arrangements

Job summary

JAG Process Solutions is seeking a Quality Assurance and CSV Associate to ensure cGMP compliance and support CSV activities within a pharmaceutical setting. You will author test scripts, maintain validation documentation, and align with regulatory expectations.

Responsibilities include developing qualification templates, collaborating across teams, and potential secondments to large pharmaceutical clients. A strong background in CSV, GDP, and GxP is essential.

Qualifications

• Bachelor's degree in engineering or related scientific/technical discipline.
• Familiarity with CSV principles, GxP environments, and Good Documentation Practices (GDP).
• Strong understanding of software QA in regulated industries.

Responsibilities

• Ensure full compliance with cGMP requirements as defined by JAG's QMS.
• Support CSV activities, including authoring and executing test scripts and documentation.
• Develop templates for qualification and validation docs (FS, DS, FAT, IQ, SAT, OQ).
• Assist PM with creation, review, and coordination of qualification deliverables.
• Keep up to date with GMP, GAMP 5, FDA guidance, and 21 CFR Part 11.

Skills

CSV validation

GxP environments

GDP

QA methodologies

Analytical skills

Education

Bachelor's degree in engineering or related scientific/technical discipline

Job description

Quality Assurance and CSV Associate – Pharmaceutical Industry

JAG Process Solutions Pty Ltd (JAG PS) is a unique process automation solutions company that has been at the forefront of innovation and technology in Europe and continues to expand its footprint in the Australian market.

Your responsibilities

Ensure full compliance with cGMP requirements as defined within JAG’s Quality Management System, maintaining strict adherence to all regulatory and quality principles.

Support Computer System Validation (CSV) activities, including authoring and executing test scripts, maintaining documentation, and ensuring alignment with regulatory expectations.

Develop and maintain templates for qualification and validation documentation, including FS, DS, FAT, IQ, SAT, and OQ.

Assist the Project Manager with the creation, review, and coordination of qualification‑related deliverables throughout the project lifecycle.

Maintain up‑to‑date knowledge of applicable regulatory and industry standards, such as GMP, GAMP 5, FDA guidance, and 21 CFR Part 11.

Collaborate effectively with internal teams and external stakeholders to ensure all quality assurance and validation requirements are met on time and to the required standard.

As part of this role, there may be an opportunity for a secondment to one of our large pharmaceutical clients.

Your profile

Bachelor's degree in engineering or a related scientific/technical discipline (preferred).

Familiarity with Computer System Validation (CSV) principles, GxP environments, and Good Documentation Practices (GDP).

Strong understanding of software quality assurance methodologies, tools, and processes within regulated industries.

Comfortable working with IT systems, PC applications, and organisational/project‑oriented tasks.

Highly self‑motivated with a positive attitude, strong analytical skills, and exceptional attention to detail.

Ability to manage competing priorities in a dynamic project environment.

Proven team player, capable of working collaboratively with multidisciplinary teams and contributing to shared project goals.

Reasons to join the team at JAG

• Extensive In-House Training: Learn from our highly experienced engineering team through structured and practical training opportunities.
• Unique Project Opportunities: Work on industry-leading projects that offer experiences rarely found elsewhere in Australia.
• Career Progression: Build your career with a growing organisation that values professional growth and advancement.
• Cutting-Edge Technologies: Contribute to innovative projects involving modern automation technologies within a world-class pharmaceutical manufacturing environment.
• Innovation-Driven Culture: Join a collaborative team that values initiative, creativity, and continuous improvement.
• Valued Contribution: Be recognised for the impact your skills and expertise make to our clients and our business.
• Employee Care: Access our Employee Assistance Program and enjoy a workplace that genuinely values its people.
• Flexible Working Arrangements: Enjoy the opportunity to work from home for part of the week while maintaining close collaboration with both the client and the team.

Remuneration and Benefits

• This is a unique opportunity to join a leading automation company with a strong reputation in its field. We pride ourselves on our collaborative culture and look forward to welcoming the right person to our team.
• We recognise the value of your skills and experience and offer a competitive salary package based on your qualifications and background. In addition to your base salary and statutory super, you will receive:
• Payment for approved hours worked beyond your contracted full-time hours.
• Applicable loadings for after-hours work.
• Eligibility for discretionary bonus payments based on both company and individual performance.