QA CSV Specialist — Hybrid/Remote in Pharma

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

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.