Junior Executive (Supervisor) 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 AchieveYour 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.

Qualifications

• 01) Manufacturing of Parenteral dosage forms02) Preferably experiences in good understanding of manufacturing and quality systems03) Handling, Storage and reconciliation of materials04) Technical knowledge on terminal sterilization of the products with respect to microbial lethality05) Knowledge on D value, F0 value, Z value calculation and sterilization cycle06) Good documentation practices and data integrity07) Ability to write and revise standard operation procedures and related manufacturing documents08) Strong interpersonal skills communication skills09) Analytical thinking to grasp complex technical issues and provide feasible solutions10) Decision making on activities in the area according to GMP procedures11) Ability to communicate effectively with all levels within the organization12) Ensure terminal sterilization as per procedures13) Activity planning and deploying the personnel according to the plan14) Ensure area upkeep with adequate identification of machines and materials15) Conduct real time batch record review in assigned area16) Enforce discipline of the personnel working in the process area17) Ensure compliance of change room behavior and personal hygiene to procedures18) Ensure adequate cleaning, sanitization of the equipment and area and housekeeping19) Ensure avoidance of cross contamination and / or mix ups20) Coordinate supporting functional departments for smooth operation of production activity21) Ensure all the performed activities comply with respective procedures22) Ensure the completeness of documentation for all performed activities23) Initiating CCFs related to documents, equipment. Ensuring their closure and implementation of the changes within specified time24) Ensure training compliance for house keeping personnel / contractors as per the requirement25) Identify deviations / exceptions and escalate to manager by appropriate procedures26) Active participation in the investigations related to exceptions and during equipment maintenances27) Disposal of rejects and waste generated during processing and other related activities28) Initiate and assist with investigations as applicable29) Monitor assigned area for compliance to SOPs and c GMP30) Adherence to safety procedure / GMP & GDP practices31) Preparation of trial run protocols related to exceptions32) Raise requests to Engineering in the event of break down / Maintenance Certify the same after completion33) Ensure compliance of operations to c GMP and safety practices at all stages of activities34) To participate in internal & external ( Regulatory & Non Regulatory) audits35) To Prepare the procedures pertaining to area in compliance to regulatory requirements36) Ensure documents pertaining to the respective area of work is on lines as per c GMP and GDP37) Submit the documents to the documentation cell on time38) Should be able to work in all shifts and to prepare the daily activity report
• 39) Complete the training of all applicable procedures as per schedule
• 40) Training the team on relevant procedures and getting trained on respective area of work

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 :
accountssalesbank reconciliationaccountingmisstrong interpersonal skillsequal employment opportunitycontinuous improvement facilitationlean toolsquality checkprocess designtechnical skillssafety practices