Australian Natural Therapeutics Group – Armidale NSW
Based in Armidale, NSW, Australian Natural Therapeutics Group (ANTG) produces exclusive high-quality cannabinoid-based medicinal treatments that can meet individual patient needs.
About the role
The QA Associate will support the Quality Assurance Manager in ensuring ANTG procedures are adhered to for the release of Bulk and finished products.
All aspects of this role are performed in accordance with the Therapeutic Goods Administration Release for Supply of Medicines and technical guidance on the interpretation of the PIC / S Guide to GMP.
Responsibilities
Conduct release activities for materials and batch release Support all Quality Assurance and Compliance needs across the site Ensure GMP personnel and processes adhere to GMP, QMS procedures and relevant legislations/guidelines Provide input to site annual product quality reviews Lead, facilitate and coordinate any corrective or preventative action prior to implementation Facilitate all onsite quality systems tasks according to QMS requirements (change control, deviation, non-conformance, CAPA, etc.)
Conduct quality checks through GACP / GMP manufacturing areas Support internal audits Promote compliance throughout the ANTG team Ensure equipment cleaning, maintenance and calibration are performed according to written procedures Maintain equipment maintenance, calibration and qualification documentation and records in accordance with written procedures and PIC / S Coordinate all site changes made according to QMS requirements Support the supplier quality program through the review and approval of vendor change notifications, raw material specifications and raw material release About you
Bachelor of Science (Life Sciences), Pharmacy or related discipline preferred but not essential At least two years of previous experience in a GMP cleanroom/aseptic environment, focusing on Quality Assurance Well versed in GMP regulations and local Quality/Regulatory legislations Knowledge of PIC / S, ICH, GAMP, GDP Proficient user of Microsoft Word and Excel Demonstrated strong interpersonal communication skills High attention to detail with excellent time management skills Capability of working with minimal supervision Analytical thinker and solution finder/problem solver Our commitment to Diversity & Inclusion:
We are an inclusive company and our ambition is to attract, recruit and promote diverse talent.
To Apply:
Please click APPLY to forward your resume and cover letter.
Please note all shortlisted candidates must pass all required background checks including a Medical (Drug and Alcohol) & Police check.
While we appreciate all applications we receive, only candidates under consideration will be contacted.
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