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Quality Assurance Associate
2 weeks ago
About Probiotec:
Probiotec is a leading provider of contract manufacturing and packing services in the pharmaceutical and associated sectors, providing best-in-class solutions to a diverse range of clients. Since beginning operations in 1997, Probiotec has quickly emerged as a leading manufacturer and packer of a diverse, high-quality range of prescription ('Rx') and over-the-counter ('OTC') pharmaceuticals, complementary medicines and consumer health products.
The business is also one of Australia's largest packing companies, offering a multitude of packing services – including primary, secondary & co-packing capabilities as an end-to-end manufacturing and packing partner. With multiple sites across Australia including Probiotec Multipack, Southpack Laboratories, ABS, LJM and Probiotec Pharma, the group is responsible for employing over 1000 employees nationwide. As a leader in Australian manufacturing and packing services, Probiotec provides innovative healthcare products that improve the lives and well-being of our customers.
Key Responsibilities:
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Manage Vendor Assurance program and ensure vendor compliance with Probiotec standards.
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Assist in the maintenance of Quality Management System.
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Assist in the management of customer/regulatory body audits, internal and external audits
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Preparation/Review of standard operating procedures where necessary.
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Perform deviation investigation and document any issues that arise from the deviation.
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Prepare change control, temporary variations, and risk assessment as and when required.
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Monitor implementation of corrective actions and evaluate effectiveness.
Desirable Qualifications & Experience:
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Degree in Science or other related field.
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Experience with implementation of corrective action programs, knowledge of tools, concepts, and methodologies of QA.
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Experience in a GMP-regulated environment.
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Strong communication skills, both written and verbal.