Knowledge and skill
Technical skills:
Basic knowledge of pharmaceutical industries, machines cleaning operation and maintenance.
Understand workplace safety and related procedures (First aid)
Basic Knowledge on Pharmaceutical industries and its standards.
Good communication skills.
Knowledge on basic trouble shooting.
Standards, Process and policies:
Basic understanding of cGMP, global quality standard and data Integrity.
Behavioral/ any Other skills:
Attention to details
Willingness to take direction and adhere to procedures
Basis understanding of hygiene, Clean room work culture.
Proper utilization of personal protective equipment during activities.
Responsibilities
Equipment installation and qualification:
Participate in the installation, site acceptance test, Installation qualification, operation qualification, Process qualification and Re-qualification of equipment in the respective functional area.
Participate in the execution of equipment qualification, performance verification and process validation
Ongoing Operation
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
Quality management and Compliance
Follow cGMP and safety at all stages of manufacturing activity.
Compliance to Pfizer integrity principles at all stages of manufacturing.
Participate in internal and external (Regulatory and Non-regulatory) audits.
Documentation
Prepare the daily activity report. Complete the documents online as per cGMP and GDP.
Preparation of user requirement specification (URS), standard operating procedures, change controls forms and corrective action and preventative action and support investigation.
Responsible for protocols preparation execution, completion, review and submission and retrieval to document cell and validation as per requirement.
Training
To Attend training for all the applicable procedures as per the schedule before performing the job.
Should be able to providing training to the trainees.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Manufacturing
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