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 whilst working onsite at Pharmaxis.

Responsibilities:

Production/Manufacturing -
1. Day-to-day responsibility for all manufacturing activities.
2. Provide technical expertise with regards to continuous improvement of production efficiencies, equipment maintenance and processes.
3.Organize and supervise the manufacturing, packaging and dispatch activities of Pharmaxis Ltd products.
4. Assist in co-ordination of receiving, sampling, manufacturing and packaging, and delivery activities.
5. Co-ordinate with quality assurance and production staff to ensure required products are manufactured and released in a timely manner.
6. Ensure all production activities are carried out and documented in accordance with cGMP (PICS, FDA etc.) and TGA licence requirements.
7. Lead and implement process improvement initiatives to create cost, quality and process efficiencies.
8. Review and release work in progress for further processing.
9. Liaise directly with suppliers on technical issues and procurement of production supplies.
10. Liaise with Clinical/Marketing departinents regarding product requirements. Liaise with other internal departments (Engineering, Quality Assurance) to solve production related problems.
11. 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.
12. Coordinate maintenance schedule with Engineering department.

Material -

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

Warehouse Operations -

1. Support warehouse operations when required, including receiving, dispatch, sampling, Navision, Inaterial handling and scheduling of warehouse operations

Documentation -

1. Write and review Process Instructions and equipment SOPs.
2. Write and review incident reports, change requests corrective action reports and risk assessments.
3. Review production related equipment breakdown and modification records.
4. Authorise documents when Production Manager absent/unavailable.
5. Conduct GMP investigations and risk assessments
6. 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.
7. Complete production documents, and maintain necessary usage, cleaning and calibration
8. Document Control-ensure all documents are up to date and periodic reviews are conducted as required.

Clean Room -

1. 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.
2. Organise scheduled cleaning of the clean room.
3. Ensure that the clean room is fully stocked.

Staff -
1. Translate production requirements into daily work schedule and direct staff in the execution of the work.
2. Encourage team members to be innovative and motivated.
3. Perforln annual performance evaluations, monitor attendance and address disciplinary issues.
4. Perform responsibilities of department head & authorised person when required.

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

Safety Compliance -
1. Ensure all work is perforned in a safe manner in accordance with the ArnaPharma OH&S policy.

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

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