Production Supervisor

Position Overview:
The main responsibility of the Production Supervisor is to oversee and support the effective operations of the production team with the goal of ensuring that quality, productivity, and dispatch requirements are met at all times. The position will encompass managing a team including Operators, packaging personnel, manufacture chemists, and other support personnel to the production department. The Production Supervisor will be responsible for the supervision and continued safety of these staff while working onsite at Pharmaxis.

Responsibilities:

• Day-to-day responsibility for all manufacturing activities.
• Provide technical expertise with regards to continuous improvement of production efficiencies, equipment maintenance, and processes.
• Organize and supervise the manufacturing, packaging, and dispatch activities of Pharmaxis Ltd products.
• Assist in coordination of receiving, sampling, manufacturing, and packaging, and delivery activities.
• Coordinate with quality assurance and production staff to ensure required products are manufactured and released in a timely manner.
• Ensure all production activities are carried out and documented in accordance with cGMP (PICS, FDA, etc. ) and TGA license requirements.
• Lead and implement process improvement initiatives to create cost, quality, and process efficiencies.
• Review and release work in progress for further processing.
• Liaise directly with suppliers on technical issues and procurement of production supplies.
• Liaise with Clinical/Marketing departments regarding product requirements. Liaise with other internal departments (Engineering, Quality Assurance) to solve production-related problems.
• Assist with process validation and revalidation work as specified in the validation plans. Participate in projects associated with site expansion, plant extension, increased storage, or alteration.
• Coordinate maintenance schedule with Engineering department.

Material:

• Purchase necessary materials and equipment to ensure the smooth operation of the cleanroom and associated facility.
• Conduct regular stocktakes of raw materials; work in process and finished products.
• Ensure materials are purchased from approved suppliers only.

Warehouse Operations:

• Support warehouse operations when required, including receiving, dispatch, sampling, Navision, material handling, and scheduling of warehouse operations

Documentation:

• Write and review Process Instructions and equipment SOPs.
• Write and review incident reports, change requests corrective action reports, and risk assessments.
• Review production-related equipment breakdown and modification records.
• Authorize documents when Production Manager absent/unavailable.
• Conduct GMP investigations and risk assessments.
• Maintain manufacturing records and update Navision, the Enterprise Resource Planning database system completion; sign off completed batch records before handover to Quality Department for release.
• Complete production documents and maintain necessary usage, cleaning, and calibration.
• Document Control-ensure all documents are up to date and periodic reviews are conducted as required.

Clean Room:

• Implement procedures to ensure the clean rooms and storage areas are kept clean and free of defects and to ensure the integrity of the clean room is maintained.
• Organize scheduled cleaning of the clean room.
• Ensure that the clean room is fully stocked.

Staff:

• Translate production requirements into daily work schedule and direct staff in the execution of the work.
• Encourage team members to be innovative and motivated.
• Perform annual performance evaluations, monitor attendance, and address disciplinary issues.
• Perform responsibilities of department head & authorized person when required.

Compliance:

• Ensure compliance in accordance with SOPs, cGMP, TGA, and FDA requirements and take corrective action where required.
• Maintain compliance with company policies, safety standards, and good housekeeping practices.
• Ensure data integrity compliance for all systems in the production area. Ensure assessments are performed and only approved users are permitted access to systems.
• Ensure all Production and Warehouse staff are complying with cGMP requirements.

Safety Compliance:

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

Training:

• To conduct on-the-job training and formal training of others where required.
• Assess the training needs of production personnel and ensure training and retraining is carried out as necessary.

Emergency Response Capability:

• Readiness to respond swiftly and effectively during equipment breakdowns or emergencies, ensuring minimal disruption to production.
• Strong analytical abilities to identify root causes of equipment malfunctions or process deviations.
• Skill in interpreting equipment manuals, schematics, and technical documentation to facilitate troubleshooting and repairs.
• Ideally, some experience operating and maintaining pharmaceutical manufacturing equipment, including blister packing, encapsulation, mixers, and packaging machinery.

Bachelor of Science or Applied Science degree in Chemistry, Pharmacy, Engineering, or a closely related discipline.

The Production Supervisor must have the following level of experience in, or knowledge of:

• Exposure in a pharmaceutical environment.
• Excellent knowledge of SOPs and cGMP requirements.
• Experience in writing scientific protocols and reports.

The employee should possess the following personal attributes (i. e. abilities and behaviors):

• Excellent Leadership skills
• Time management
• Initiative
• Analytical ability
• Problem-solving
• Good Technical aptitude
• Effective Communication Skills (Oral and Written)
• Attention to Detail
• Professional Manner

Flexibility, shift work, own transport

Negotiation Skills

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 Production Supervisor position at Arna Pharma. Join us in our mission to innovate healthcare and improve lives around the world. Please send your resume to Only Australi.