Arna Pharma Pty Ltd is an innovation-driven pharmaceutical company dedicated to enhancing lives through the development and manufacturing of high-quality, differentiated products. With a strong presence in over 23 countries across North America, Europe, Asia, and Oceania, Arna Pharma is committed to delivering innovative solutions that improve patient outcomes. Arna Pharma operates state-of-art manufacturing facilities in Frenchs Forest, accredited by TGA, US-FDA, EU-GMP, ANVISA, and other regulatory bodies, the facility specializes in the production of Bronchitol and Aridol. It is equipped with advanced machinery, including Niro PSD 5 Spray Drier, Planeta MG2 100 encapsulating machine, and Uhlmann B1240 Thermoformers Blister packer.

Position Description:

The Plant Manager is responsible for the 20 Rodborough Road Frenchs Forest plant including site and equipment contained within the facility. The Plant Manager leads the Facility team including Process Engineers, Facility Engineers and any other staff within that scope (e.g. Fitters). The following lies within the scope of the Plant Manager role:

Manage the facility and plant/equipment to meet current and future plans of Arna Pharma.

Authoriszor and final approver for the team including, but not limited to, change control, deviation control, document authorizer.

Develop procedures, policies and controls for the department.

Prepare operational and capital budgets on a yearly basis to meet the business plan goals and objectives for the plant and facility.

Ensure the facilities, equipment and other resources are available to enable management and staff to carry out their functions in a safe, efficient and effective manner.

Hard and soft facility management, asset management, auditing and compliance, QMS, and adherence to responsible WHS practices.

Position Duties:

Head of Department- Facility

Co-ordinate and direct all Engineering projects relating o facility and plant equipment.

Authorizer and final approver for the team on new and/or updated controlled documentation owned by the facility department, and on quality incident documentation relevant to the plant

Develop procedures, policies and controls for the Operations group.

Ensure all quality related incident reports are:

Ensure activities, performed in the operations group, are conducted in accordance with global regulatory bodies' regulations and guidelines.

Prepare and participate in site inspections performed by various global regulatory bodies.

Participate in developing the overall Arna Pharma business plans, goals and objectives.

Setting the direction of the Engineering department in accordance with the Arna Pharma business plan, goals and objectives, and directing the resources and activities of the departments accordingly.

Prepare operational and capital budgets on a yearly basis to meet the business plan goals and objectives for the operations group.

Ensure the facilities, equipment and other resources are available to enable management and staff to carry out their functions in a safe , efficient and effective manner.

Liaise with building owners and subleased parties regarding maintenance and works for the facility and site.

Ensure that the facility security remains at a level expected from a cGMP manufacturing site.

Project Management

Participate and manage maintenance/improvement projects associated with the manufacturing equipment, site expansion, plant extension, increased storage or alteration.

Maintenance management

Manage the maintenance and calibration schedule and procedures-ensure that the Engineering department's maintenance and calibration activities are completed appropriately and on schedule. Review of completed records and determining any necessary follow-up actions,

Write and review equipment/engineering SOPs as required.

Organize and/or carry out routine maintenance of equipment as required.

Ensure adequate spare parts are available for critical equipment.

Department Management

Maintain adequate employment levels through selecting, interviewing, and training of personal. Ensure initial and continual training is provided to and completed by all department personnel. Ensure on-going GMP training.

Maintain a training schedule and plan for personnel. Ensure competency of personnel performing tasks.

Conduct performance reviews for direct staff and implement objectives and development plans for department staff.

Safety Compliance

Ensure all work is performed in a safe manner in accordance with the Arna Pharma WHS policy.

Implement and supervise safety measures and procedures associated with the facility and plant equipment.

What we are looking for:

A Plant manager have the following level of experience in, or knowledge of:

Machine design for purpose of troubleshooting or developing/modifying equipment to suit specific needs.

Electrical understanding for troubleshooting control systems and integrating controls into new equipment.

Facility and associated services design and operation for management and improvement of manufacturing, laboratory and general building areas.

Regulations and standards to ensure installations comply with regulatory authorities.

Awareness of market value, quality and suitability to purpose of equipment for assessment of quotations.

Sound knowledge of GMP requirements.

Core Competencies:

Serve others to improve their operational efficiency and job fulfilment.

Lateral thinking to provide and assess alternatives for troubleshooting and new equipment needs.

Adaptable to change in objectives due to external circumstances.

Additional Competencies:

Desire to complete projects proficiently.

Able to seek assistance when required.

Continual desire to development and learn.