Quality Specialist Healthcare

Quality Specialist Healthcare

Sydney

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 youll 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 escalate quality risks to leadership and recommend mitigation strategies

About you

• Strong understanding of regulatory requirements in Australia and New Zealand

• 45 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)

• Handson experience supporting audits and regulatory inspections

• Confident communicator with a proactive solutionsfocusedmindset

• Degree in Pharmacy or a Biosciences discipline (preferred)

Why join

• 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