Broad Function

Responsible for the supervision and GMP compliance of the Cleanroom facility and employees. Responsibilities include the monitoring of Cleanroom department performance against predefined business objectives and maintaining GMP excellence in accordance with the company’s strategic plan. To support and take part in day-to-day production of low-bioburden serum in the TGA approved Cleanroom facility as per standards of Code of Good Manufacturing Practice (cGMP) and assist in supervision and training of cleanroom staff to meet production demands. Ensuring the efficient running of the facility and adherence to the manufacturing schedule.

This role will be a 15-month maternity leave cover

Principle Responsibilities

Actively partake in and sustain the production of export grade FDA/TGA approved product in the Turretfield Production facility via appropriate preparation of materials and equipment.

To review the manufacturing planning schedule and proactively support the Cleanroom team to meet it.

Carrying out the specified cleaning procedures and ensuring that the Cleanroom team performs and records cleaning of process equipment and plant in accordance with relevant documentation and procedures. Complete routine assessments of cleaning activities to ensure the facility requirements are met.

Prepare and communicate operational objectives to achieve department strategy, specifically around Quality, Safety and Operational Efficiency.

Ensure that the validation and calibration schedule for the facility equipment and systems is maintained and trending reports are completed each quarter on relevant equipment and in line with the requirements of the Site Validation Master Plan.

To conduct, review and generate metrics for batch manufacturing data collection activities and ensure such data that has been collected is accurate and utilised to monitor the performance and consistency of the process.

Complete assigned duties such as, but not limited to, investigations and corrective actions.

Skills and Attributes

Excellent understanding of cGMP and EHS legislation and ability to translate to operational details and communicate to staff.

Competent, methodical, highly organised individual who pays strict attention to detail and has the ability to effectively prioritise and execute tasks within a high-pressure environment. Organisational skills should be strong with an ability to plan ahead.

Capable of working with minimum supervision.

Demonstrated problem solving skills in identifying and resolving issues.

Ability to execute tactical plans and maintain established timelines and budgets.

Ability to develop and maintain strong working relationships with support functions.

Experience of collating and presenting departmental KPIs.

Driver’s license is required.