Pharma Stability Lead: GMP/TGA Compliance & Impact

Lipa Pharmaceuticals Limited; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Immediate start with onsite carparking

Results-driven team

Ongoing training and support

Supportive management with clearVision

Rewards and Recognition program

Job summary

Lipa Pharmaceuticals Limited is seeking a Stability Coordinator to manage the end-to-end stability program in compliance with TGA and GMP. The role collaborates with QA, Regulatory Affairs and Production to ensure product integrity across lifecycles.

The successful candidate will schedule stability samples, perform HPLC/GC/FTIR/UV-Vis testing, maintain documentation, and review data to identify trends and excursions. Onsite parking and career development are offered.

Qualifications

• 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.

Responsibilities

• Coordinate and maintain the site stability program in accordance with TGA, GMP and ICH guidelines.
• Schedule and manage stability samples for ongoing and new 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.

Tools

HPLC

GC

FTIR

UV-Vis

Job description

Lipa Pharmaceuticals Limited is seeking a Stability Coordinator to manage the end-to-end stability program in compliance with TGA and GMP. The role collaborates with QA, Regulatory Affairs and Production to ensure product integrity across lifecycles.

The successful candidate will schedule stability samples, perform HPLC/GC/FTIR/UV-Vis testing, maintain documentation, and review data to identify trends and excursions. Onsite parking and career development are offered.