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Principal Specialist QA Tech Ops

SeniorFull-timeHybridMelbourne VIC, AustraliaPosted 3 weeks agoVerified 3 weeks ago
Pending fitX of Y criteria met

About the job

This job is about providing quality oversight across manufacturing operations at Moderna's Melbourne facility, which plays a crucial role in enhancing Australia's biotech landscape. The impact of this job is significant, as it contributes to global health security through the production of mRNA vaccines. The team values collaboration and innovation, creating an environment where every interaction is an opportunity to learn and make a meaningful impact.

You'll be responsible for

✅

Providing quality oversight

Providing quality oversight for commissioning, qualification, and validation activities associated with drug product manufacturing equipment, systems, facilities, and critical utilities.
🔧

Supporting QA oversight

Supporting and providing QA oversight for the process validation lifecycle, including validation strategy, process performance qualification, and continued process verification.
📄

Reviewing validation documentation

Reviewing and approving validation documentation, ensuring records are scientifically sound and aligned with site and global quality system requirements.

Key criteria

🎓

Bachelor's degree in science or engineering

Essential educational background for quality oversight in biotech.

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🕔

5+ years of GMP experience

Proven experience in pharmaceutical quality and validation processes.

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🔧

Equipment qualification expertise

Demonstrated skills in equipment qualification within GMP environments.

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View more

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5 criteria for this job
Bachelor's degree in science or engineering
Essential educational background for quality oversight in biotech.

View

5+ years of GMP experience
Proven experience in pharmaceutical quality and validation processes.

View

Equipment qualification expertise
Demonstrated skills in equipment qualification within GMP environments.

View

Experience with risk assessments
Proven ability to conduct risk assessments in quality management.

View

Strong technical writing skills
Experience creating GMP and validation documentation is crucial.

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A meaningful career starts with a match

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