Manufacturing Line QC Specialist – GMP & Quality Systems

Probiotec; Melbourne; On-site; AUD 70,000 - 100,000; Full time

Job summary

Probiotec in Melbourne is seeking an experienced Quality Assurance professional to oversee GMP-compliant production operations and maintain robust QA systems. The role requires coordinating between Production, Warehouse and Quality teams, reviewing SOPs, and driving continuous improvement through deviations, changes and risk assessments.

You will ensure staff training, document control, calibration, and validation activities are carried out, while upholding hygiene standards and regulatory

Qualifications

• 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.

Responsibilities

• 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.

Skills

Bachelor of Science

QA

GMP

Regulatory knowledge

Documentation

Education

Bachelor of Science or equivalent

Job description

Probiotec in Melbourne is seeking an experienced Quality Assurance professional to oversee GMP-compliant production operations and maintain robust QA systems. The role requires coordinating between Production, Warehouse and Quality teams, reviewing SOPs, and driving continuous improvement through deviations, changes and risk assessments.

You will ensure staff training, document control, calibration, and validation activities are carried out, while upholding hygiene standards and regulatory