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Supervisor-Terminal Sterilization

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 Supervisor-Terminal Sterilization

Job Description

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
  • 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 lethality

    o Should have knowledge on D value, F value, Z value and sterilization cycle

    o Basic understanding of cGMP, global Pfizer quality standards and data integrity

    o Attention to detail

    o Willingness to take direction and adhere to procedures

    Equipment installation and qualification

    o Participate in the installation, SAT, IQ, OQ, IOQ, PQ of new equipment in the respective functional area

    o Participate in the execution of the equipment qualification, performance verification, PRQ and process validation

    Ongoing operation

    o Maintain personnel hygiene

    o Be aware of and always adhere to change room procedures

    o Must have the ability to work effectively both independently and as a part of team

    o Check for proper housekeeping in his / her area .

    o 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

    o Execute the sterilization cycle according to the BMR andspecifications

    o Perform the operation and cleaning of the equipment as per procedures

    o Receive pallets to be sterilized as per procedure from the pre sterilization area

    o Place the received pallets in the autoclave and sterilize the load as per procedures.

    o After completion of the sterilization cycle remove the pallets from the autoclave and send it to the visual inspection or post sterilization hold area

    o React to the alarms and ensure the smooth processing of work

    o Perform the status labelling as per procedures

    o Ensure the equipment maintenance of as per procedures

    o Must be able to perform various functions of a repetitive nature while maintaining concentration of task

    o Achieve the required output as per the norms

    o Simplifying the process by innovation

    o Accountable for the area and equipment upkeep

    o Hand over the shift at the end of shift and to take charge for the shift

    o Coordinate with cross functional department and participate in preventive and breakdown maintenance of equipment and machines

    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.

    Documentation

    o Prepare the daily activity report.

    o Complete the documents on-line as per cGMP and GDP

    Training

    o 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

Job Classification

Industry: Engineering & Construction
Functional Area: Production, Manufacturing, Maintenance,
Role Category: Production/Manufacturing/Maintenance
Role: Production/Manufacturing/Maintenance
Employement Type: Full time

Education

Under Graduation: Any Graduate
Post Graduation: Post Graduation Not Required
Doctorate: Any Doctorate, Doctorate Not Required

Contact Details:

Company: Pfizer
Location(s): Visakhapatnam

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Keyskills:   Process design Housekeeping Training Equipment qualification Breakdown maintenance Compliance Pharma GMP Equipment maintenance Quality management

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