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QA Associate – Validation
Chemist Warehouse. Develop, implement and maintain Sigma's Validation Master Plan and qualification framework .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and maintaining Validation Master Plans and qualification frameworks, with a strong focus on GMP compliance and quality management systems. Proficient in technical writing, risk assessments, and supporting regulatory inspections and audits.
Highest-signal resume keywords
Validation Master Plan DevelopmentGMP ComplianceComputerised System Validation (CSV)Technical WritingQuality Assurance Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation DocumentationRisk AssessmentIQ/OQ/PQ ProtocolsValidation ReportsTemperature MappingChange ControlCAPA ManagementSOP DevelopmentQuality SystemsAnalytical Skills
Soft Skills
Attention to DetailAutonomous WorkCollaboration
Industry Keywords
GxP SystemsQuality Management SystemsRegulatory ComplianceInternal AuditsCustomer Audits
About the role
Key responsibilities & impact- 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 URS, risk assessments, IQ/OQ/PQ protocols and validation reports
- Support Computerised System Validation activities, including GxP systems and data integrity requirements
- Coordinate temperature mapping programs and support temperature excursion investigations
- 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 with operations, facilities and quality teams to strengthen GMP compliance
- Contribute to continuous improvement initiatives enhancing quality systems and regulatory compliance
- Support implementation, management and maintenance of validation and qualification systems under the Quality Manager
Requirements
What you’ll need- 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
- Excellent technical writing and documentation skills
- Strong analytical skills and exceptional attention to detail
- 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) highly regarded
Benefits
Comp & perks- Wide range of learning and development programs
- Internally designed leadership pathway
- Annual salary reviews linked to performance
- Work from home one day per week
- Flexible case-by-case arrangements for personal circumstances
- Six weeks of paid parental leave for primary carers
- One week of paid parental leave for secondary carers
- Employee discounts across a wide range of products through Flare
- Corporate offers on Bupa Healthcare premiums
- Banking benefits with Comm Bank
- Novated leasing
- Confidential Employee Assistance Program (EAP) services
- Subsidised onsite canteen
- Complimentary shuttle bus connecting nearby train stations to the Preston Support Office