Pharmaceutical Production Operator

About The Role Position Overview:

The role of a Pharmaceutical Production Operator involves a diverse range of activities. These activities may include;

• Handling of materials,
• Assembly, set up and operation of pharmaceutical equipment such as the spray dryers, blending,

capsule filling, blister packing and secondary packaging equipment to produce the finished product.

• Equipment cleaning and sanitising.
• Completion of documentation associated with production tasks- batch records, cleaning forms,

inventory forms etc.

• Cleanroom cleaning and housekeeping.
• Participating in the secondary packaging process.

Materials -

• Handle and label materials appropriately and with care as detailed in SOPs.
• In-process sampling according to procedure.
• Enter consumption and output data into Navision, the Enterprise Resource Planning database system.
• Ensure only approved materials are used (unless otherwise advised).
• Store materials appropriately.
• Assist in warehouse operations; carry out incoming goods receiving and product dispatch operations

as required.

• Identify and report to Supervisor any irregularities, incidents etc. associated with materials.

Operation and Maintenance of Equipment -

• Set-up and operate production equipment.
• Ensure production equipment operates within predetermined parameters.
• Execute routine maintenance of equipment as required.
• Perform equipment cleaning as required to meet cGMP regulations.
• Participate in and perform experimental trials/development work to improve or correct processes.
• Trouble-shooting of equipment.
• Participate in secondary packaging operations when required.

Documentation -

• Review procedures and processes. Contribution to procedures may be required.
• Read updates to documentation as required and implement updates in relevant process.
• Ensure batch document paperwork is signed and completed to meet cGMP requirements.
• Partake in risk assessments and investigations where required.

Clean-room -

• Ensure the clean room and storage area are kept clean and free of defects. Complete scheduled

cleaning and supervise contract cleaners when required.

• Ensure the pressure differentials; temperature, relative humidity and the status of the room are

compliant prior to commencing manufacture of a batch.

• Avoid causing excursions in cleanroom/warehouse environmental conditions (e.g. blocking vents,

introducing foreign particles to area etc.).

• Environmental monitoring of the cleanroom i.e. particle count monitoring.
• Supervise visitors/contractors upon entry to the Clean Room.

Safety Compliance -

• Ensure all work is performed in a safe manner in accordance with the Arnapharma OH&S policy and

specific procedures.

Training -

• To conduct on the job training and formal training of others in cleanroom procedures were necessary.

Complete regular GMP training as instructed.

GMP -

• All Operators are trained in specific processes, which incorporate good manufacturing practice. Each

Operator is responsible for following these procedures and carrying out activities in a GMP compliant

manner.

• Operators are obliged to report and compliance issues, incidents etc. to Production Senior

Management so effective and precise corrective actions can be taken immediately

Requirements Education:

• High school diploma or equivalent secondary education certification. Completion of vocational training, technical courses, or certification programs related to manufacturing, production operations, or pharmaceutical processing is desirable but not essential.

Experience

• The pharmaceutical production operator must have the following level of experience in, or knowledge of; o Clean room procedures and practices

Core Competencies

• The pharmaceutical production operator should possess the following personal attributes;
• Effective Communication Skills (Oral and Written)
• Attention to Detail
• Ability to work independently and as part of a team
• Display good attendance Professional Manner

Additional Competencies The pharmaceutical production operator ideally would have some of the following personal attributes;

• Proficiency in the use of computers including Windows, Excel and Microsoft Word.
• Flexibility
• Good time management skills
• Initiative
• Good technical/troubleshooting skills.
• Own transport (Morning/Afternoon shift work is required)

About The Company Arna Pharma is a leading pharmaceutical company dedicated to improving global healthcare through innovative solutions. With a focus on research, development, and manufacturing of high-quality pharmaceutical products, Arna Pharma aims to address unmet medical needs and enhance patient outcomes worldwide.

Equal Opportunity Employer Arna Pharma is an equal opportunity employer and is committed to diversity in the workplace. We celebrate the unique qualities and perspectives of each individual and encourage applications from all qualified individuals, regardless of race, ethnicity, gender, sexual orientation, age, religion, disability, or veteran status.

Join Our Team We invite you to apply for the Pharmaceutical Production Operator at Arna Pharma. Join us in our mission to innovate healthcare and improve lives around the world. Please send your resume to [email protected]. Only Australian Citizens / Permanent Resident / Work right visa holders can apply, no sponsorship provided.