Senior Quality Associate, China

H&H Group | B Corptm; Melbourne; Hybrid; AUD 90,000 - 120,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Quality systems

Root cause analysis

Deviation investigations

Documentation control

Cross-functional collaboration

Stability program management

Training & induction

Microsoft Excel

Communication

Travel readiness

Education

Relevant tertiary qualification in science or engineering

Tools

Microsoft Office

Job description

The variety of work creates unlimited opportunities to excel across a breadth of disciplines; you will be presented with a wealth of new pathways and opportunities to explore throughout your career. Working with us will be more than just a job; we guarantee a life-changing experience as you step into an environment that moves quickly and presents new challenges daily.

Reporting to the Quality Manager, the Senior Quality Associate ensures all aspects of Quality Operations are carried out. You will manage the end-to-end quality aspects of NPD and EPD projects, from CM briefs, product specifications, risk assessments, stability evaluation and timely, compliant first commercial batch release. You will lead deviation and OOS/OOT investigations, approve product specifications, liaise with contract manufacturers, support the stability program, manage change controls, and attend commercial production when required. You will also support the Quality System Team with PIC/S GMP compliance, foster Continuous Improvement and Right First Time, and proactively address risks with a can-do attitude.

Sign off product specification for new and existing products

Manage change controls

Manage ongoing stability, including signing off stability protocols, raising POs, with local and international contract manufacturers.

Liaise with contract manufacturers regarding non-conformances and customer complaints

Liaise with cross functional teams during new product development

Arrange external contract testing (e.g. chemical and micro testing) with approved laboratories, set up new areas of testing, and manage accounts, samples and results.

Liaise with strategic suppliers and CMs (including occasional visits, as required), and manage scheduled ‘Quality Connects’.

Prepare and review metrics for the Management Review.

Notify the Quality Manager of significant quality challenges that may affect product quality or regulatory compliance (e.g. OOS, OOT), and of key Quality and Compliance metrics.

Participate in document control (SOPs / WIs), and new employee induction and ongoing training where required.

Participate in supplier qualification, including review of GMP/Quality Agreements.

Demonstrate the Swisse pledge for benchmark standards, and participate in Good Documentation Practice (GDP) and Good Housekeeping Practice (GHP).

Desired Skills & Experience

We look for people who have what it takes to make an impact; who can challenge us to go further while pushing themselves to deliver exciting & ambitious results.

To make sure we’re setting new starters up for success, we ask that you meet a few criteria relevant to the role to be considered for this opportunity:

Experience in pharmaceutical or complementary medicines manufacturing.

Investigating deviations and OOSs using root cause analysis tools and implementing corrective and preventative actions.

Experience with document control, change control, product quality reviews, complaints management, stability program management, and training and induction of new employees.

A relevant tertiary qualification in science or engineering, or at least 5 years’ experience in a similar pharmaceutical or regulated medical industry.

Understanding of regulatory requirements for therapeutic and non-therapeutic products, including working knowledge of quality systems, risk management and compliance, plus knowledge of laboratory operations.

Proficiency in Microsoft Office (Word and Excel) and quality management systems.

Excellent written, verbal, presentation, organisational and follow-up skills.

Strong problem-solving, team-building, planning, decision-making and time management skills, with the ability to analyse and critically assess information and provide guidance and advice based on your experience.

Mandarin is desirable but not mandatory.

This role is based in Sydney (hybrid)

Ability to travel at short notice (mainly within Sydney and occasionally interstate)

H&H Group believes in the benefits of a diverse & inclusive workplace & aims to reflect the varied cultures within which we exist. We are committed to providing a working environment that is free from discrimination & harassment,creating a safe and inclusive environment for all.

We encourage applications from people of all ages, nationalities, religions, racial and gender identities,sexual orientations, abilities and cultures, & our hiring decisions will be based on business needs, position requirements, & the qualifications and experience of individuals. If you require support or assistance during the application process, please notify us at the time of application and we will be sure to enable reasonable adjustments where suitable.