AstraZeneca1 follower7 jobs

Senior Specialist Quality Assurance (Compliance Team)

SeniorContractOfficeNew South Wales, AustraliaPosted 5 days agoVerified 6 days ago
Pending fitX of Y criteria met

About the job

The Senior Specialist, Quality Assurance (Compliance) is a vital position at AstraZeneca, focusing on elevating Pharmaceutical Quality Systems and ensuring inspection readiness. This job offers the opportunity to drive continuous improvement in a collaborative environment that values autonomy and practical problem-solving. Join a team that is dedicated to pushing the boundaries of science and making a difference in the lives of patients.

You'll be responsible for

🔧

Owning and operating PQS subsystems

Leading defined elements such as deviations/investigations, CAPA, change control, and regulatory compliance activities.
📚

Acting as the site-level system guide

Holding/authoring SOPs, providing end-user training, and ensuring master data alignment to quality requirements.
📝

Driving inspection readiness

Planning and leading preparation for internal and external inspections, compiling evidence packs, and leading follow-up actions.

Key criteria

🔍

GMP Quality Assurance experience

Minimum 3 years in pharmaceutical quality systems.

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📊

System ownership capability

Experience with SOP authorship and critical metric management.

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🤝

Stakeholder communication skills

Proven ability to engage cross-functional teams and leadership.

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Meet the team

Think you're a good fit?See what the hiring team are looking for

About the company

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4 criteria for this job
GMP Quality Assurance experience
Minimum 3 years in pharmaceutical quality systems.

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System ownership capability
Experience with SOP authorship and critical metric management.

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Stakeholder communication skills
Proven ability to engage cross-functional teams and leadership.

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Digital literacy
Proficiency in MS applications and quality management systems.

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