JoinDKSH Healthcareand take ownership of product quality across ANZ. This role is key to ensuring compliant product release, leading supplier audits, and strengthening our Quality Management System.
About the role
As the Quality Specialist, you willlead oversight of product quality across DKSH Healthcare ANZ, working closely with internal teams and external partners to ensure regulatory compliance and continuous improvement.
What you’ll do
Be responsible foroverall product quality across DKSH Healthcare ANZ
Support and/or perform quality release activities and release recommendationsin accordance withGDP/GMP and sponsor requirements
Act as a key Quality representativeduring audits andregulatoryinspectionsincludingconducting periodic onsite and virtual supplier audits
Support responses to audit observations and ensuretimely, effective CAPA implementation and closure
Author andmaintainSOPs within the Quality Management System (QMS)
Drive continuous improvement initiatives across the QMS
Uphold and promotehigh standardsof regulatory compliance and product quality across the organisation
Own andmaintainkey elements of the Quality Management System, including SOP review cycle management and the Quality Manual
Proactivelyidentifyand elevatequality risks to leadership and recommend mitigation strategies
About you
Strong understanding of regulatory requirements in Australia and New Zealand
4–5 years’ experience in Quality, particularly in Product Quality & Release or Distribution Quality roles
In-depth knowledge of Good Distribution Practice (GDP) and/or Good Manufacturing Practice (GMP)
Experience working with healthcare distributors, sponsors, or pharmaceutical companies
Proven experience working within a Quality Management System (QMS)
Hands on experience supporting audits and regulatory inspections
Confident communicator with a proactive, solutionsfocusedmindset
Degree in Pharmacy or a Biosciences discipline (preferred)
Highimpact role with trueend-to-endquality ownership
Opportunity to work within a global, growing healthcare organisation
Collaborative, purposedriven team environment
Supporting, high-performing team within a Great Place to Work-certified organisation
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Quality Specialist (Sydney - Hybrid) employer: DKSH
At DKSH Performance Materials, we pride ourselves on being an excellent employer that fosters a collaborative and innovative work culture. Our Australian team offers extensive growth opportunities for early-career professionals, allowing you to develop your commercial skills while building meaningful relationships in the specialty chemicals sector. With a focus on employee development and a supportive environment, we empower our staff to contribute to our success and make a real impact in diverse industries.
