Pact's APM Contract Manufacturing division manufactures and packs for nutraceutical, herbal, vitamin, mineral and nutritional supplements. Tablets, hard capsules and powdered products are produced in our in our state of the art, TGA compliant facility in Keysborough.
Our uniquely flexible and purpose-built facilities utilise the latest blending, granulating and packaging technologies, allowing us to maintain the fastest project completion times in the industry.
Job Description
About this opportunity
Reporting to the Product Development Manager, The Regulatory and Stability Associate is responsible for ensuring product compliance with the relevant regulatory bodies. The associate coordinates stability studies to assess label claims and active efficacy.
• Liaise with sponsor and coordinate with external testing facility to conduct stability tests and studies • Reviewing stability data to establish shelf-life and trend evaluations • Review and assess regulatory market compliance for medicines • Prepare medicine submissions to the relevant regulatory bodies • Ensure product safety and active efficacy is reviewed and safe for use • Review product claims and label requirements and ensure compliance is met • Aid investigations of Out of Specification/Out of Trend (OOS/OOT) results and assist in determining root cause
Your key responsibilities will be to:
•Liaise with sponsor and coordinate with external testing facility to conduct stability tests and studies
• Review stability data to establish shelf-life and trend evaluations
• Review and assess regulatory market compliance for medicines
• Prepare medicine submissions to the relevant regulatory bodies
• Ensure product safety and active efficacy is reviewed and safe for use
• Review product claims and label requirements and ensure compliance is met
• Aid investigations of Out of Specification/Out of Trend (OOS/OOT) results and assist in determining root cause
Your skills and experience
To be successful in this role, you’ll have:
* A keen eye for detail
* Advanced SAP and Excel experience
* Strong interpersonal, communication & presentation skills
* Qualifications
in Chemical engineering