Senior Quality Lead - NPD/EPD & GMP (Hybrid SYD)

H&H Group | B Corptm; Melbourne; Hybride; AUD 90 000 - 120 000; Plein temps

Résumé du poste

H&H Group in Sydney is seeking a Senior Quality Associate to lead end-to-end quality activities for NPD and EPD programs. You will manage specifications, risk assessments, stability, and first commercial batch release, while addressing deviations and CAPAs.

You will liaise with contract manufacturers, support the stability program, and drive PIC/S GMP compliance and continuous improvement. The role requires a tertiary science/engineering qualification with at least 5 years in pharma or regulated

Qualifications

• Experience in pharmaceutical or regulated medical industry.
• Experience with deviations, OOS/OOT investigations and CAPA.
• Experience with document control, change control and quality reviews.
• Understanding of regulatory requirements for therapeutic and non-therapeutic products.
• Proficiency in MS Word and Excel; good GMP knowledge.

Responsabilités

• Lead end-to-end quality aspects of NPD and EPD projects.
• Sign off product specifications and manage change controls.
• Oversee stability program and signing off stability protocols.
• Collaborate with contract manufacturers and manage quality from labs to production.
• Support PIC/S GMP compliance and continuous improvement initiatives.
• Address risks with proactive, data-driven approaches.

Connaissances

Quality systems

Root cause analysis

Deviation investigations

Documentation control

Cross-functional collaboration

Stability program management

Training & induction

Microsoft Excel

Communication

Travel readiness

Formation

Relevant tertiary qualification in science or engineering

Outils

Microsoft Office

Description du poste

H&H Group in Sydney is seeking a Senior Quality Associate to lead end-to-end quality activities for NPD and EPD programs. You will manage specifications, risk assessments, stability, and first commercial batch release, while addressing deviations and CAPAs.

You will liaise with contract manufacturers, support the stability program, and drive PIC/S GMP compliance and continuous improvement. The role requires a tertiary science/engineering qualification with at least 5 years in pharma or regulated