Founded in 1849, Pfizer is the worlds premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Team Leader - Terminal Sterilization
Job Description
• 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.
Technical Skills
Knowledge of the following :
• Manufacturing of parenteral dosage forms
• Preferably experiences in good understanding of manufacturing and quality systems
• Handling, storage and reconciliation of materials
• Technical knowledge on terminal sterilization of the products with respect to microbial lethality
• Knowledge on D value, F0 value, Z value calculation and sterilization cycle
Standards, Processes & Policies
• cGMP and application of quality management systems
• Good documentation practices and data integrity
• Technical writing and document review skills
• Ability to write and revise standard operation procedures and related manufacturing documents
Behavioral/Any Other Skills
• Strong interpersonal skills communication skills
• Analytical thinking to grasp complex technical issues and provide feasible solutions
• Decision making on activities in the area according to GMP procedures and Pfizer global policies.
• Ability to communicate effectively with all levels within the organisation
Responsibilities
Equipment installation and Qualification
• Participate in execution of installation FAT,SAT,IQ,OQ,IOQ,PQ of new equipment in the respective functional area
• Participate in the execution of periodic requalification and process validation
Operations
• Ensure terminal sterilization as per procedures.
• Activity planning and deploying the personnel according to the plan.
• Ensure area upkeep with adequate identification of machines and materials
• Conduct real time batch record review in assigned area
• Enforce discipline of the personnel working in the process area
• Ensure compliance of change room behaviour and personal hygiene to procedures
• Ensure adequate cleaning, sanitization of the equipment and area and housekeeping
• Ensure avoidance of cross contamination and / or mix ups
• Coordinate supporting functional departments for smooth operation of production activity
• Ensure all the performed activities comply with respective procedures.
• Ensure the completeness of documentation for all performed activities.
• Review of all related protocols (Qualification/Non Routine Validations/ Trial Run Protocols).
• Initiating CCFs related to documents, equipment. Ensuring their closure and implementation of the changes within specified time
• Ensure training compliance for housekeeping personnel / contractors as per the requirement.
• Identify deviations/exceptions and escalate to Manager by appropriate procedures.
• Active participation in the investigations related to exceptions and during equipment maintenances.
• Disposal of rejects and waste generated during processing and other related activities.
• Initiate and assist with ER investigations as applicable
• Monitor assigned area for compliance to SOPs and cGMP
• Adherence to safety procedures/GMP & GDP practices
• Preparation of trial run protocols related to exceptions.
• Raise requests to Engineering in the event of breakdown / maintenance
Quality Management and Compliance
• Ensure compliance of operations to cGMP, safety and Pfizer integrity principles at all stages of activity
• To participate in internal & external (Regulatory & Non-Regulatory) audits
Documentation
• To prepare the procedures , pertaining to area in compliance with regulatory requirements/corporate guidelines/practices
• Ensure to fill/write the documents pertaining to the respective area of work on-line as per cGMP and GDP and submit the documents to the production documentation cell on time
• To prepare the daily activity report
Training
• To attend the training of all applicable procedures as per schedule.
• Training the team on relevant procedures and getting trained on respective area of work
Candidate Profile
• Bachelor's Degree in Mechanical / Chemical engineering (B.E./B.Tech.) or Pharmacy (B.Pharm)
• 3+ years of experience in Sterile Injectable or relevant Pharma industury. Do not apply, if you are from other industries.
• Prior relevant Leadership experience in a regulated manufacturing operations environment. Perferred if you have experince of handling team of 3-5 personnel.
• Working knowledge of Upstream/Downstream Current Good Manufacturing Practices (cGMP) manufacturing operations
• Excellent leadership, communication, and interpersonal skills. Good command on English is required.
• Ability to work in a dynamic, fast-paced and goal driven environment with strong decision making capability.
• Should be ready to work in all the shifts as per the organiations requirements.
Additional Information :
Experience : 3+ years of experience
Qualification : B.E./B.Tech or B.Pharm
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Terminal Sterilization
End Date : 30th May, 2022
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