The primary objective of this position is to facilitate Sydney based complementary manufacturer in their relevant processes and systems to comply with local regulatory requirements and relevant authority in Australia.
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Core Job Responsibilities:
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Core Job Responsibilities
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- Sampling of raw material and onsite laboratory testing. Review all test results and store all documentation.
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- Analytical method development for the raw material & finished products
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- Issue and maintain the GIN register. Track and maintain up to date GIN register
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- Perform packaging material inspection and maintain and update packaging documentation
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- Maintain and update the batch manufacturing records and batch packaging records
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- Performs in-process checks on all production and packaging lines
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- Review and record environmental monitoring data such as temperature, humidity
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- Performs sampling of the purified water system
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- Ensure GMP standards are adhered to by all production staff
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- Meet the requirementstoCode of GMP by complying with all relevant Quality policies and procedures to ensure the Quality objectives of the business are met.
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- Establish and maintain specifications and standards for control of raw material; packaging and finished products.
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- Manage/coordinate company quality system.
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- Coordinate / perform / assist with product registration process include research therapeutic functions of current products and prepare and submit ARTG listing application.
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- Support other departments on technical and quality issues especially Sales / Production / Operations departments.
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- Maintain existing licenses and acquire required licenses/certificate as needed.
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- Maintain the company MVP programs include carry out IQ/OQ/PQ, process validation and cleaning validations.
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- Assist QA manager throughout the day-to-day function as required
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Knowledge / Education Required:
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Minimum Bachelor of Science or Engineer or equivalent.
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Experience Required:
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Hand on experience required in QC level to perform this job.
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Must have been a quality control experience in pharma/complementary industry with minimum 1 years experience.
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KnowledgeofAustralian Health AuthorityTGAregulationsa must with understanding of basic principles in HACCPpreferable.
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Preference will be provided to candidates with previous experience in a complementary manufacturing facility.
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📌 Senior QC Associate with Lab testing experience (New South Wales)
🏢 Star Combo Australia
📍 New South Wales
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