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The Level III Production Operator (Technician III) executes, runs autonomously and advises colleagues complex activities of aseptic manufacturing of batches, billable activities, or continuous improvement activities required in the production department, following instructions and standard operating procedures in accordance with the AEMPS, FDA, and other regulatory agencies under supervision. In addition, they must ensure the execution of production plans, following all company safety guidelines. A high level of detail is required due to the complexity of the activities to be performed.
Job Responsibility:
Execute complex activities of aseptic manufacturing of batches
Ensure execution of production plans following safety guidelines
Work as a team, supporting and inspiring co-workers
Comply with schedule prioritization
Collaborate in identification of continuous improvement opportunities
Participate in preparing for regulatory agency or client inspections
Participate in control of plant consumables stock
Collaborate in investigations of quality events
Inform manager of equipment anomalies or human errors
Inform manager of safety equipment or resource needs
Collaborate with other departments
Take care of equipment functioning
Lead activities of dispensing and preparing materials
Lead activities of set up grade D/C and A/B
Lead activities of formulation processes grade C and A/B
Lead activities of filtration processes grade C and AB
Support filling activities
Support execution of sterilizable equipment SIP
Train Technicians level II
Requirements:
Comply with manufacturing area safety regulations and work practices
Comply with the requirements of cGMP, AEMPS, FDA and other regulatory agencies
Operate production equipment following guidelines
Participate in the manufacture of products following manufacturing guides
Handle pallet trucks
Review relevant SOPs and production lot records
Complete and maintain documentation
Maintain cleanliness and order of production areas
Demonstrate a general knowledge of aseptic techniques
Successful participation in gowning qualification and media fill plan
Perform sanitization of materials
Disinfect classified and non-classified clean production rooms