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Senior qc analyst – method development

Sydney
Autopak-Vetlab Group
Posted: 13 December
Offer description

Senior QC Analyst – Method Development & Validation

With more than 40 years of experience, we're a trusted, independent contract manufacturer producing animal health and agricultural products for some of the biggest names in the industry. Based in St Marys, we're proud of our technical depth, quality focus and collaborative culture.

We're now seeking a Senior Analyst – Method Development & Validation to provide specialist leadership in analytical method development, validation and verification.


About the Role

Reporting to the Technical Director, you'll take ownership of analytical method development, validation and technology transfer activities across a wide range of dosage forms. You'll work closely with internal and external stakeholders to ensure methods are scientifically sound, regulatory-compliant and fit for purpose.


Key Responsibilities

* Design and execute method development, validation and verification studies in line with relevant guidelines.
* Lead analytical technology transfers (internal and external), preparing and reviewing protocols and reports.
* Provide expert input to complex investigations and non-routine analyses.
* Maintain robust validation documentation in collaboration with QA and Documentation teams.
* Train QC Analysts on new and revised methods, ensuring competence is assessed and recorded.
* Liaise with customers and regulatory bodies regarding method and validation queries.
* Support the introduction of new technologies, instrumentation and analytical techniques.


About You

* Degree in Chemistry or related field (postgraduate qualification desirable).
* Extensive experience in analytical method development and validation within a GMP/GLP environment.
* Strong understanding of pharmacopeial methods and regulatory expectations.
* High technical rigour, excellent documentation discipline and attention to detail.
* Collaborative and able to influence across teams.
* Confident communicator, comfortable interacting with customers and auditors.


Why Join Us

This is a key technical role in a growing, independent manufacturer with a strong reputation for quality and innovation. You'll have the opportunity to apply your scientific expertise, lead challenging projects, and help shape the future of our analytical capability.

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