SENIOR QUALITY ASSURANCE MANAGER — NSW

Probiotec Multipack, Kemps Creek | Full time

ABOUT PROBIOTEC

Probiotec is a leading provider of contract manufacturing and packing services in the pharmaceutical and associated sectors, providing best-in-class solutions to a diverse range of clients. Since beginning operations in 1997, Probiotec has quickly emerged as a leading manufacturer and packer of a diverse, high-quality range of prescription ('Rx') and over-the-counter ('OTC') pharmaceuticals, complementary medicines and consumer health products.

The business is also one of Australia's largest packing companies, offering a multitude of packing services – including primary, secondary & co-packing capabilities as an end-to-end manufacturing and packing partner. With multiple sites across Australia including Probiotec Multipack, Probiotec LJM and Probiotec Pharma, the group is responsible for employing over 1000 employees nationwide. As a leader in Australian manufacturing and packing services, Probiotec provides innovative healthcare products that improve the lives and well-being of our customers.

This role is based at our current state-of-the-art Kemps Creek facility.

THE ROLE

Probiotec Multipack provides co-packing services across pharmaceutical, food, personal care and animal health product, working under TGA, HACCP and APVMA requirements.

The Senior Quality Assurance Manager NSW leads the Quality Department at our Kemps Creek facility, managing and developing the quality team and holding responsibility for the site quality system and GMP compliance. The role works alongside Operations to make sure product meets regulatory and customer requirements,



and represents the site in TGA, customer and third-party audits.

KEY RESPONSIBILITIES

- Lead the Quality Department — set priorities, manage workload and performance, and hold the team accountable for quality outcomes.
- Build the capability of the team — coach and develop your quality staff and identify training needs.
- Hold delegation as Authorised Person for Release for Supply, and train and qualify other Authorised Personnel to perform it.
- Approve or reject packaging materials, bulk and finished product, verify completion of production records prior to release, and set sampling, inspection and storage requirements.
- Own the site quality system — authorise and approve SOPs, work instructions, protocols and packaging instructions, and maintain records across the data lifecycle.
- Advise the business on TGA, PIC/S, GMP, APVMA, HACCP and ISO requirements.
- Coordinate external, customer and regulatory audits, evaluate findings and close out corrective actions.
- Conduct internal GMP inspections and manage deviations, change control, CAPA and non-conformances.
- Investigate customer complaints and provide investigation outcomes and CAPAs back to customers.
- Approve and monitor suppliers of materials and providers of GMP outsourced activities.
- Ensure qualification,



validation and maintenance of premises, processes and equipment, and oversee cleaning and sanitisation controls for packaging equipment and clean rooms.
- Conduct Product Quality Reviews and monitor stability requirements through the product sponsor.
- Support customer onboarding from a quality perspective, including GMP and quality agreements.
- Apply a risk-based approach across processes, analyse quality data to target improvements, train production operators so GMP and change control are applied on the floor, and support the site's EHS programs.

SKILLS AND ATTRIBUTES

- Experience performing Release for Supply as an Authorised Person at a TGA-licensed site — you will hold this delegation at Kemps Creek.
- Tertiary qualification in science, pharmacy or a related discipline.
- Demonstrated experience managing a team in a manufacturing or packing workplace, including performance management and development. This is a leadership role, not a technical specialist role.
- Substantial GMP experience at a TGA-licensed pharmaceutical manufacturing or packing site.
- Strong working knowledge of the PIC/S Guide to GMP and TGA regulatory requirements.
- Experience hosting TGA, customer and third-party audits, and writing responses that stand up to scrutiny.
- Confident across deviations, change control, CAPA, validation and product quality review.
- A clear, practical communicator who can pitch quality requirements to operators, managers and customers.
- Sound judgement under pressure, and the ability to hold the compliance line while understanding production and commercial realities.

📌 Senior Quality Assurance Manager (Sydney)
🏢 Probiotec Multipack
📍 Sydney