Junior Officer-Terminal Sterilization

Job Description

Why Patients Need YouOur breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.What You Will AchieveAs 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.

• Knowledge of the following:
  • o Knowledge of pharmaceutical machine operation, cleaning and maintenance
  o Understands workplace safety and related procedures( e.g. First Aid)o Knowledge on terminal sterilization of the products with respect to microbial lethalityo Should have knowledge on D value, F value, Z value and sterilization cycleo Basic understanding of cGMP, global Pfizer quality standards and data integrityo Attention to detailo Willingness to take direction and adhere to proceduresEquipment installation and qualificationo Participate in the installation, SAT, IQ, OQ, IOQ, PQ of new equipment in the respective functional areao Participate in the execution of the equipment qualification, performance verification, PRQ and process validationOngoing operationo Maintain personnel hygieneo Be aware of and always adhere to change room procedureso Must have the ability to work effectively both independently and as a part of teamo Check for proper housekeeping in his / her areao Receive the daily consumableso 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 mannero Execute the sterilization cycle according to the BMR and specificationso Perform the operation and cleaning of the equipment as per procedureso Receive pallets to be sterilized as per procedure from the pre sterilization areao Place the received pallets in the autoclave and sterilize the load as per procedures.o After completion of the sterilization cycle remove thepallets from the autoclave and send it to the visual inspection or post sterilization hold areao React to the alarms and ensure the smooth processing of worko Perform the status labelling as per procedureso Ensure the equipment maintenance of as per procedureso Must be able to perform various functions of a repetitive nature while maintaining concentration of tasko Achieve the required output as per the normso Errors to be escalated to supervisorso Simplifying the process by innovationo Accountable for the area and equipment upkeepo Perform the cleaning and sanitization of the area as per the procedureso Handle waste and rejects as per procedures.o Hand over the shift at the end of shift and to take charge for the shifto Coordinate with cross functional department and participate in preventive and breakdown maintenance of equipment and machines.o Should be able to work in all the shifts
  • Quality Management and Compliance
  o Follow cGMP and safety at all stages of manufacturing activity.o Compliance to Pfizer integrity principles at all stages of manufacturing.o Participate in internal & external (Regulatory and Non-regulatory) audits.Documentationo Prepare the daily activity report.o Complete the documents on-line as per cGMP and GDPTrainingo To attend the training for all the applicable procedures as per the schedule before performing the job.o Should be able to providing training to the trainees when deemed necessary

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Manufacturing #LI-PFE,

Keyskills :
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