Supervisor-Terminal Sterilization

Job Description

Your expertise in the manufacturing domain will help to ensure that the process area operates in safe and GMP compliant manner at all times. You will help in developing and managing performance of a team of process technicians. Your role will be to build upon and improve existing process design to optimize process, facility and equipment used while conforming to SOPs and cGMP requirements. You will maintain regulatory compliance through established programs for testing, maintenance, training, SOPs, validation, and cleaning in your area of responsibility.As a Team leader, you will be involved in leading work teams within a division. You will lead the people, technical and financial resources of the team. Thanks to your technical skills, you will coach your direct reports on day to day activities. You will be relied on to solve complex problems within your area of expertise. It is your dedication that will make it possible for Pfizer s customers and patients to receive the medicines they need, when they need them.How You Will Achieve It

• Manage multiple projects and work activities (timelines, work plans, deliverables) within the team.
• Support development of SMART Objectives for the full team.
• Participate in Pfizer Network programs, to ensure best practice sharing.
• Assist with the development of your unit from commissioning, through to start-up, validation, and {Current} Good Manufacturing Practices {part of GxP} operations.
• Lead System Application & Products Materials process for Shift.
• Perform quality check on processing activities and process confirmations of Integrated Manufacturing Excellence (IMEx) elements.
• Drive implementation and embedding of Lean Tools in the area.
• Act as interface between management team and functional team.
• Support Shift Colleagues Individual Development Plan.
• Ensure contingent staff are managed appropriately in terms of performance and training.

• Knowledge of the following:oKnowledge of pharmaceutical machine operation, cleaning and maintenanceoUnderstands workplace safety and related procedures( e.g. First Aid)oKnowledge on terminal sterilization of the products with respect to microbial lethalityoShould have knowledge on D value, F value, Z value and sterilization cycleoBasic understanding of cGMP, global Pfizer quality standards and data integrityoAttention to detailoWillingness to take direction and adhere to proceduresEquipment installation and qualificationoParticipate in the installation, SAT, IQ, OQ, IOQ, PQ of new equipment in the respective functional areaoParticipate in the execution of the equipment qualification, performance verification, PRQ and process validationOngoing operationoMaintain personnel hygieneoBe aware of and always adhere to change room proceduresoMust have the ability to work effectively both independently and as a part of teamoCheck for proper housekeeping in his / her area.oMust 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 manneroExecute the sterilization cycle according to the BMR andspecificationsoPerform the operation and cleaning of the equipment as per proceduresoReceive pallets to be sterilized as per procedure from the pre sterilization areaoPlace the received pallets in the autoclave and sterilize the load as per procedures.oAfter completion of the sterilization cycle remove thepallets from the autoclave and send it to the visual inspection or post sterilization hold areaoReact to the alarms and ensure the smooth processing of workoPerform the status labelling as per proceduresoEnsure the equipment maintenance of as per proceduresoMust be able to perform various functions of a repetitive nature while maintaining concentration of taskoAchieve the required output as per the normsoSimplifying the process by innovationoAccountable for the area and equipment upkeepoHand over the shift at the end of shift and to take charge for the shiftoCoordinate with cross functional department and participate in preventive and breakdown maintenance of equipment and machinesQuality Management and ComplianceoFollow cGMP and safety at all stages of manufacturing activity.oCompliance to Pfizer integrity principles at all stages of manufacturing.oParticipate in internal & external (Regulatory and Non-regulatory) audits.DocumentationoPrepare the daily activity report.oComplete the documents on-line as per cGMP and GDPTrainingoTo 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

Keyskills :
certified tips trainerequal employment opportunitycontinuous improvement facilitationlean toolsmusic makingquality checkprocess designtechnical skills