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The Level III Production Operator (Technician III) executes, runs autonomously and advises colleagues complexs 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. The minimum training time for this normally is 4 years.
Job Responsibility:
Executes, runs autonomously and advises colleagues complex activities of aseptic manufacturing of batches, billable activities, or continuous improvement activities required in the production department
Ensure the execution of production plans, following all company safety guidelines
Requirements:
Comply with manufacturing area safety regulations and work practices in accordance with all company health, safety and environmental programs
Work as a team, being approachable, practical, motivating, able to support and inspire your co-workers
Comply with the schedule by following the prioritization instructions of their senior managers
Collaborate in the identification of opportunities for continuous improvement
Comply with the requirements of cGMP, AEMPS, FDA and other regulatory agencies
Collaborate and participate in preparing for inspections by regulatory agencies or clients
Participate in the control of the stock of plant consumables
Collaborate in the investigations of the different quality events (deviations, capas, change controls...)
Inform the direct manager when anomalies are detected in the operation of equipment or human errors
Inform the direct manager if safety equipment or human resources needs are identified
Collaborate in teamwork with other departments if required
Take care of and ensure the proper functioning of the equipment
Operate production equipment following the guidelines indicated in the work procedures
Participate in the manufacture of the different products following the indications of the manufacturing guides
Handle pallet trucks for the movement of goods
Review relevant sops and production lot records
Complete and maintain documentation related to assigned work
Comply with and maintain cleanliness and order of production areas
Supports the activities of the qualification of production equipments
Demonstrate a general knowledge of aseptic techniques
Successful participation in the gowning qualification as well as the media fill plan
Leads the activities of dispensing and preparing materials
Perform the sanitization of materials prior to their introduction into the manufacturing areas
Disinfect classified and non classifies clean production rooms
Leads the activities of set up grade D/C
Leads the activities of set up grade A/B
Leads the activities of formulation processes grade C
Leads the activities of formulation processes grade A/B
Leads the activities of the activities of filtration processes grade C
Leads of the activities of filtration processes grade AB
Supports filling activities
Supports the activities of sip execution of sterilizable equipment
Supports the activities of sip execution of complex sterilizable equipment