14 Oct
|
Lipa Pharmaceuticals
|
Sydney
14 Oct
Lipa Pharmaceuticals
Sydney
Lipa Pharmaceuticals is Australia's leading manufacturer of complementary medicines, specialising in vitamins, pharmaceuticals, and health food supplements. We have the capacity to produce a wide range of products including tablets, hard and soft capsules, liquids, powders, creams, gels, and probiotics.
We are proud to have been recognised by Complementary Medicines Australia as the 'High-Quality Manufacturer of the Year' on nine occasions for the exceptional products we create.
The Opportunity
We currently have a fantastic opportunity available for a Stability Coordinator on a full time permanent basis. The Stability Coordinator is responsible for the end to end management of Lipa Pharmaceuticals stability program ensuring stability testing of finished products is in compliance with TGA requirements.
This role plays a critical part in monitoring product quality throughout its shelf life by conducting analytical testing, maintaining stability programs and ensuring accurate documentation and reporting. The Stability Coordinator works closely with Quality Control, Quality Assurance, Regulatory Affairs and Production teams to ensure products remain safe, effective and compliant throughout their lifecycle.
What we offer
Immediate start with onsite car parking
Work with a results-driven and passionate team
Ongoing training and support
Guidance by a supportive management team with a clear vision
Employee benefits, including a Rewards and Recognition Program
Responsibilities
Coordinate and maintain the site stability program in accordance with TGA, GMP and ICH guidelines.
Schedule and manage stability samples for ongoing and current products.
Ensure correct storage and monitoring of stability samples under controlled environmental conditions.
Monitor, record and review temperature and humidity data for stability chambers and elevate any excursions.
Perform physical and chemical testing of stability samples in accordance with approved specifications.
Conduct analytical testing using techniques such as HPLC, GC, FTIR, UV-Vis and other relevant methods.
Prepare and standardise reagents and solutions required for laboratory testing.
Review and compare analytical results against approved specifications and stability protocols.
Trend and analyse stability data to identify potential quality issues.
Accurately document all testing activities in compliance with GMP and TGA requirements.
Maintain stability protocols, reports and summary documentation for regulatory purposes.
Support investigations relating to out-of-specification (OOS), out-of-trend (OOT) results and deviations.
Assist with preparation of stability reports for regulatory submissions and product registrations.
Experience in a Quality Control or Stability laboratory within the pharmaceutical or complementary medicine industry
Strong understanding of GMP, TGA and ICH stability guidelines
Hands-on experience with analytical instrumentation (HPLC, GC, FTIR, UV-Vis, etc.)
Strong data analysis and trending skills
High attention to detail and strong documentation skills
Ability to manage timelines and coordinate multiple stability schedules
Strong communication and teamwork skills
Please Note
Lipa Pharmaceuticals has a strong commitment to health and safety, with a pre-employment medical requiring successful completion, prior to an offer being made. We do not accept unsolicited applications from third parties. Applicants must be eligible to work in Australia. Additionally, as our facility is not accessible by public transport you will need your own transportation to get to work.
Lipa Pharmaceuticals is an Equal Employment Opportunity (EEO) employer. We are committed to providing a diverse and inclusive work environment for all employees and applicants, regardless of race, colour, nationality, gender, age, disability, religion, sexual orientation, gender identity, or any other characteristic protected by law. We encourage individuals from all backgrounds to apply
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📌 Stability Coordinator (Sydney)
🏢 Lipa Pharmaceuticals
📍 Sydney