Junior Officer - Terminal Sterilization

Job Description

As part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team s success by sharing your previously acquired knowledge.It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It

• Manage own time and professional development, be accountable for own results and begin to prioritize own workflow.
• Responsible for the preparation and/or operation of various components, materials, equipment, machines including, but not limited to any and/or all applicable components, materials, equipment, machines in the assigned area(s).
• Complete adherence to all plant safety and (current) Good Manufacturing Practices {also cGMP} regulations to the highest.
• Assist with diagnosis and troubleshooting activities and execute in-process quality inspections.
• Ensure adequate inventory of parts and materials prior to initiating a production run.
• Identify and seek to implement process and safety improvement and perform all tasks in a safe manner.
• Participate in shift meetings, provide hand off information and communicate with other units and shifts.

QualificationsEquipment installation and qualification

• Participate in the installation, SAT, IQ, OQ, IOQ, PQ of new equipment in the respective functional area
• Participate in the execution of the equipment qualification, performance verification, PRQ and process validation

Ongoing operation

• Maintain personnel hygiene
• Be aware of and always adhere to change room procedures
• Must have the ability to work effectively both independently and as a part of team
• Check for proper housekeeping in his / her area
• Receive the daily consumables
• Must have demonstrated knowledge of equipment operation, should be able to read and interpret equipment data, demonstrate ability to communicate work requirements and problems in a concise and accurate manner
• Execute the sterilization cycle according to the BMR and specifications
• Perform the operation and cleaning of the equipment as per procedures
• Receive pallets to be sterilized as per procedure from the pre sterilization area
• Place the received pallets in the autoclave and sterilize the load as per procedures.
• After completion of the sterilization cycle remove the Pallets from the autoclave and send it to the visual inspection or post sterilization hold area
• React to the alarms and ensure the smooth processing of work
• Perform the status labelling as per procedures
• Ensure the equipment maintenance of as per procedures
• Must be able to perform various functions of a repetitive nature while maintaining concentration of task
• Achieve the required output as per the norms
• Errors to be escalated to supervisors
• Simplifying the process by innovation
• Accountable for the area and equipment upkeep
• Perform the cleaning and sanitization of the area as per the procedures
• Handle waste and rejects as per procedures.
• Hand over the shift at the end of shift and to take charge for the shift
• Coordinate with cross functional department and participate in preventive and breakdown maintenance of equipment and machines

Quality Management and Compliance

• Follow cGMP and safety at all stages of manufacturing activity.
• Compliance to Pfizer integrity principles at all stages of manufacturing.
• Participate in internal & external (Regulatory and Non-regulatory) audits.

Documentation

• Prepare the daily activity report.
• Complete the documents on-line as per cGMP and GDP

Training

• To attend the training for all the applicable procedures as per the schedule before performing the job
• Should be able to providing training to the trainees when deemed necessary

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Keyskills :
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