Manufacturing (Compounding) Operator Full Time

Role Summary

This position is responsible for the manufacturing activities of bulk products on a day-to-day basis in accordance with manufacturing schedule, Standard Operating Procedures (SOP) requirements, current Good Manufacturing Practice (cGMP) requirements and as directed by Team Leader/Head of Manufacturing Production. 

General Responsibilities

• Responsible for ensuring that all bulk manufacturing tasks are executed in a safe and compliant manner with company policies, safety policy and OH&S standards (including the use of Personal Protective Equipment (PPE) and machine guards as required).
• Responsible for ensuring all manufacturing tasks are performed in accordance site SOP, Manufacturing Work Orders (MWO) and Good Manufacturing (GMP) requirements.
• Responsible to ensuring that correct, accurate and approved raw materials are used for batch manufacture and any deviation from this practice escalated to Head of Manufacture/Quality.
• Responsible for ensuring that bulks are mixed/produced and stored in accordance with MWO and SOP requirements.
• Responsible for ensuring all raw materials (liquids and solids) are sealed to prevent cross contamination.
• Responsible for ensuring all manufacturing information (batch documents, logbooks) is recorded in accordance with ALCOA principles (Attributable, Legible, Contemporaneous, Original and Accurate). 
• Responsible for ensuring areas (manufacturing, dispensary and airlock) and equipment are in clean and good working order, any malfunctions must be escalated to Head of Manufacture in a timely manner.
• Responsible for ensuring manufacturing equipment are within calibration due date and escalate to Head of Manufacture if equipment is out of calibration.
• Responsible for cleaning manufacturing equipment (vessels, emulsifiers, transfer pumps and paths) in accordance with SOP and site safety requirements using approved cleaning agent.
• Responsible for dismantling manufacturing equipment parts (paddles, mixers) and cleaning them prior to assembling, ready for batch manufacture in accordance with SOP and site safety requirements using approved cleaning agent. 
• Responsible for participating and supporting internal audit program, regulatory audits and investigations related to bulk manufacturing difficulties.

Job Specific Responsibilities

Prepare equipment in accordance with GMP and SOP requirements, ensuring all necessary documentation are completed in a timely fashion.

• Lead compounding activity for batches scheduled.
• Ensure the manufacturing procedures and processes are in compliance with the GMP and safety requirements.
• Weighing out specified types and quantities of liquid or solid raw ingredients via manual scales, according to MWO including Dispensing and handling and sampling of hazardous raw materials.
• Perform mixing of bulk product batches.
• Operation of boiler, process water/purified water system and compressed air systems.
• Complete required batch documentation records, forms and logbooks.
• Ensure all raw materials being returned to the store are done so in the prescribed manner.
• Perform cleaning/sanitation or CIP of tanks and mixers.
• Inspect equipment to assure the cleaning standards are met.
• Transfer bulk product into holding vessels and from compounding to storage areas or filling lines.
• Ensure to maintain the cleanliness of the compounding area.
• Must be able to lift 20 – 25 kgs regularly.
• Must be able to work 6-2pm, 8-4pm and 10-6pm shifts.