Job Description
Melbourne, Australia | Posted on 07/08/2026
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We are looking for a Quality Assurance Engineer to join our team on a12-month contract. The Quality Assurance Engineer is responsible forproviding Quality Assurance oversight and support for
commissioning,qualification,
validation, technology transfer, process lifecycle management,capital projects, vendor qualification, and operational quality activities. This role is accountable for maintaining quality and compliance throughout theproject lifecycle while supporting successful project execution and
commercialoperations.
The incumbent is also responsible andaccountable for the execution of the PSC mission, "to maintain the integrityand professionalism of our products and services while enabling steady growthand development".
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D U T I E S A N D R Es P O NSIBI L IT IE S :
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Provide Quality Assurance oversight forengineering, validation, manufacturing, and capital project activities.
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Review and approve GMP-related
documents,including
validation protocols, qualification documents, risk
assessments,technical
transfer documentation, and quality system records.
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Support commissioning,
qualification,validation,
technology transfer, and process lifecycle activities to ensurecompliance with regulatory and company requirements.
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Facilitate and support quality systemsincluding deviations, investigations, change controls, CAPA, and riskmanagement activities.
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Ensure compliance with cGMP, GxP, siteprocedures, and applicable global regulatory requirements.
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Provide quality guidance and risk-baseddecision-making to project teams and operational stakeholders.
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Collaborate with Engineering,
Manufacturing,Validation,
Quality Control, Supply Chain, and Regulatory teams to achieveproject and business objectives.
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Participate in audits, inspections, andcontinuous improvement initiatives to maintain and enhance compliance andquality performance.
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Support vendor qualification and supplierquality activities as required.
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Additional duties and responsibilities may beassigned from time to time.
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DE M O N S TR A T E D C O M P E T E N CI ES :
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Quality &Compliance; Excellence –
Strongunderstanding
of cGMP, GxP principles, quality systems, validation
lifecyclerequirements,
and global regulatory expectations.
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Relationship Building – Works with and acrossformal and informal skilled and social networks to build long-termpartnerships and connections in the life science industry.
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Problem solving –Identifies, researches, and demonstrates logical reasoning to
communicatecritical
information.
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Rational Persuasion –, Active listening, Presents key factors influencing factors, andstrategic goals to assist stakeholders in identifying solutions.
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Interpersonal Awareness – Ability to be aware ofhow actions, ideas, and communication can/does affect people and theiroutcomes.
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Agility – Meets objectives by responding to competingand changing priorities and multiple tasks under inflexible timelines.
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Requirements
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R E QU I R E D E D UC A TI O NA N DW O RK E X P E R I E N C E :
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Bachelor's Degree in Engineeringor Life Science.
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Minimum 4 yearsof experience in Quality Assurance, Validation, , Manufacturing Quality, orProject Quality within the pharmaceutical, biotechnology, medical device, orother regulated industries.
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Demonstratedexperience
reviewing and approving GMP documentation including riskassessments, validation protocols, qualification documents, change
controls,deviations,
and CAPAs.
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Experiencesupporting
technology transfer, process validation, qualification,
engineering,manufacturing,
or capital projects.
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Working knowledge of cGMP, GxP, FDA, EMA, TGA, PIC/S, andinternational regulatory requirements.
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Strong technical writing and document review skills.
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Ability tobuild and maintain relationships with stakeholders across multiple functionsand organizational levels.
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📌 Quality Assurance Engineer (Victoria)
🏢 PSC Biotech
📍 Victoria