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Form of workAbout the business
Based in Armidale, NSW, Australian Natural Therapeutics Group (ANTG) produce exclusive high-quality cannabinoid based medicinal treatments that can meet individual patient needs. We combine a strong research focus with best in class cultivation and extraction methods to develop cannabinoid medicines that offer safe and effective therapeutic benefits to patients.
About the role
The QA Associate will support the Quality Assurance Manager in ensuring ANTG procedures are adhered 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
- Supporting all Quality Assurance and Compliance needs across 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
- Ensure equipment maintenance, calibration and qualification documentation and records are maintained 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
Relevant Experience & Requirements
- Bachelor of Science (Life Sciences), Pharmacy or related Discipline preferred but not essential
- At least two years’ of previous experience in 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
Benefits and perks
- Competitive salary package.
- A successful value driven culture with a focus on growth
- Opportunity to expand experience with good potential for career development
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.
