Quality Assurance Associate - Validation

Sigma Healthcare Limited; Melbourne; On-site; AUD 85,000 - 110,000; Full time

Benefits offered by this job

Salary reviews

Work from home 1 day per week

Paid parental leave

Employee discounts

EAP

Onsite canteen

Shuttle bus

Job summary

Sigma Healthcare is seeking a QA Associate – Validation to lead validation activities and maintain the Validation Master Plan across multiple distribution centres in Victoria and NSW. The role focuses on GMP compliance, quality systems and ensuring inspections readiness.

You will work with operations, facilities and quality teams to support audits, change controls and continuous improvement of validation processes within a regulated environment.

Qualifications

• Degree in Science or related discipline.
• Experience in Quality Assurance, Validation or Quality Systems in a regulated environment.
• Strong GMP, GWP, GDP knowledge and quality management systems.
• Experience developing and reviewing qualification/validation documentation with attention to detail.
• Excellent technical writing and documentation skills.

Responsibilities

• Develop, implement and maintain Sigma's Validation Master Plan and qualification framework.
• Plan and execute validation activities across facilities, equipment and warehouse systems.
• Prepare and review URS, IQ/OQ/PQ, risk assessments and validation reports.
• Support CSV activities and data integrity requirements for GxP systems.
• Coordinate temperature mapping programs and investigate excursions.
• Drive changes, deviations and CAPAs related to validation.

Skills

Quality Assurance

Validation

GMP compliance

Documentation

Audits

Education

Science degree

Tools

CSV (Computerised System Validation)

Job description

Quality Assurance Associate - Validation

Join Sigma Healthcare and play a pivotal role in shaping the future of quality, validation and GMP compliance across one of Australia's leading healthcare supply chains.

At Sigma Healthcare, we're undertaking an exciting transformation of our quality and compliance framework as we progress our GMP and TGA licensing journey across our distribution network. As a result, we're looking for a technically strong QA Associate – Validation to help implement, maintain and continuously improve our validation and qualification systems across our Truganina (Victoria) and Kemps Creek (New South Wales) Distribution Centres.

This is a unique opportunity to join a business where you'll help establish critical validation processes and become the long-term owner and subject matter expert for Sigma's qualification and validation program.

About the opportunity

Reporting to the Quality Manager, the QA Associate – Validation will be responsible for supporting the implementation, management and ongoing maintenance of Sigma's validation and qualification systems, ensuring they remain inspection-ready and aligned with GMP, GWP and regulatory requirements.

Working closely with operations, facilities and quality stakeholders, you will lead qualification and validation activities across facilities, equipment and computerised systems while supporting audits, inspections and ongoing compliance initiatives.

This role can be based in Truganina VIC, Preston VIC or Kemps Creek NSW, with regular travel between sites required.

What you’ll be doing

Develop, implement and maintain Sigma's Validation Master Plan and qualification framework.

Plan and execute validation and qualification activities across facilities, equipment and warehouse systems.

Prepare and review validation documentation including URS, risk assessments, IQ/OQ/PQ protocols and validation reports.

Support Computerised System Validation (CSV) activities, including GxP systems and data integrity requirements.

Coordinate temperature mapping programs and support investigations relating to temperature excursions.

Drive validation-related change controls, deviations and CAPAs.

Develop and maintain validation-focused SOPs, work instructions and training materials.

Support internal audits, customer audits and regulatory inspections.

Partner closely with operational, facilities and quality teams to strengthen GMP compliance across the distribution network.

Contribute to continuous improvement initiatives that enhance quality systems and regulatory compliance.

Who are we looking for?

We're looking for a quality professional who is passionate about GMP compliance, enjoys technical problem-solving and has the confidence to represent validation processes during audits and inspections. You'll bring:

A degree in Science or another relevant discipline.

Experience in Quality Assurance, Validation or Quality Systems within a regulated environment.

Strong working knowledge of GMP, GWP, GDP and quality management systems.

Experience developing and reviewing qualification and validation documentation with a high-level of attention-to-detail.

Excellent technical writing and documentation skills.

Strong analytical skills and exceptional attention to detail.

The ability to work autonomously while collaborating effectively with a broad range of stakeholders.

Experience supporting audits, inspections or regulatory compliance activities.

Exposure to Computerised System Validation (CSV) will be highly regarded.

Why Join us?

Grow your career with purpose – Access a wide range of learning and development programs, including our internally designed leadership pathway to support your long‑term growth. Be part of a purpose-driven organisation making a difference in healthcare, working with a collaborative and supportive team.

Be rewarded for your impact – Enjoy annual salary reviews linked to your performance, recognising the value you bring to the team.

Flexibility that works – Work from home one day per week, while staying connected with your team at our vibrant Preston Support Office four days a week. We’re committed to supporting our people through life’s important moments. Alongside our formal flexibility policies, we recognise that some circumstances, such as returning from parental leave or managing personal wellbeing may require additional consideration. In these situations, we work collaboratively on case‑by‑case arrangements to provide the support needed while balancing the requirements of the role and team.

Paid parental leave – We support growing families with six weeks of paid parental leave for primary carers and one week of paid parental leave for secondary carers.

Exclusive savings – Access generous employee discounts across a wide range of products with our partnership with Flare, including company-wide corporate offers on healthcare premiums with Bupa Healthcare, banking benefits with Comm Bank and novated leasing.

Support when you need it – Tap into confidential Employee Assistance Program (EAP) services for personal or professional support.

Take advantage of our subsidised and convenient onsite canteen for varied and affordable meals, coffee, confectionary and bakery items.

Easy commuting – Enjoy our complimentary shuttle bus connecting nearby train stations to the Preston Support Office, making public transport travel simple and stress‑free.

About us

Sigma Healthcare is powering pharmacy! We have the largest pharmacy network in Australia with trusted brands including Chemist Warehouse, Amcal, Discount Drug Stores and Ultra Beauty! We are powered by our dedicated people and our leading Australian full line pharmacy wholesale and distribution business that delivers medicines to any pharmacy anywhere in Australia. With Chemist Warehouse now operating in four countries outside Australia, we continue to expand our reach.

Ready to apply?

This is more than a validation role. It's an opportunity to help build a capability that's critical to Sigma's future. Joining at a pivotal time, working alongside experienced quality professionals and external subject matter experts while helping shape systems that will support GMP compliance, regulatory inspections and long‑term operational excellence across the business.

If you're an experienced QA or Validation professional looking to take ownership of a critical capability and help drive quality excellence in a growing healthcare organisation, we'd love to hear from you. We’re eager to talk to applicants and will be looking to commence interviews from Monday 26th October.