Manufacturing Line QC (Night Shift)

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 3 sites across Australia including Probiotec Pharma, LJM and Probiotec Multipack, 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.

Duties include:

• Prepare and/or review SOPs, Work Instructions and QD forms relating to production operations and ensure operators are complying with Code of GMP and Probiotec procedures.
• Perform deviation investigation and document any issues that arise from the deviation.
• Prepare change control, temporary variations, and risk assessment as and when required.
• Serve as the primary point of contact between Production, Warehouse, and Quality teams for any quality issues identified during manufacturing operations, ensuring timely escalation, investigation, and resolution.
• Perform line clearances at batch start‑up, and countersign batch documentation to verify compliance with specifications and regulatory requirements. Monitor implementation of corrective actions and evaluate its effectiveness.
• Ensure that the required initial and continuing training of the personnel working in Operations is carried out and adapted according to need.
• Maintain Operations personnel training records and ensure the training matrix/ register is up to date.
• Ensure establishment and maintenance of appropriate levels of plant hygiene.
• In close coordination with NPD, Engineering and Cleaning Validation personnel, ensure that appropriate validation activities are performed for the products under manufacture. This includes process validation, cleaning validation and equipment qualification.
• Monitor and routinely inspect calibration of equipment to ensure it operates correctly.
• Ensure all Quality issues are appropriately investigated and reported in a timely manner.
• Monitors production processes and periodically checks batch document and logbooks to ensure adherence to GMP and GDP.

Prerequisites:

• Bachelor of Science or equivalent degree desirable.
• A minimum of 3 years of experience in a medium to large organization.
• Experience in operational activities in a compliant environment is required.
• Experience in maintaining and developing GMP administrative systems highly desirable.
• Professional scientific competency.
• Knowledge of quality and risk management terminology and proficient knowledge of scientific terminology required.
• Understanding a wide range of Operational functions and procedures.
• Strong organisational and time management skills.