Job details
Job type full-time
Full job description
Responsible for ensuring operating state of cgmp compliance in terminal sterilization, visual inspection and packaging operations.
Maintain regulatory compliance in accordance with cgmp practices
Ensure manufacturing policies and procedures conform to pfizer standards
Knowledge and hands on experience in reviewing ebr and assessing the impact of amps exceptions with technical support/inputs from sr.specialist or supervisor.
Review of batch reports, and equipment audit trails
Perform acceptable quality level sampling, inspection and record the results in batch records for all products
Perform batch start-up and end activities vizSensor challenge tests, recipe review, and etc.
Perform random process checks for terminal sterilization, visual inspection and packaging
Perform daily walkthroughs and report observations to the supervisor.
Perform equipment breakdown assessments w.r.t to product quality and patient safety with technical support/inputs from sr.specialist or supervisor.
Review and assessment of equipment alarms and review of quarterly alarm trends.
Report any non-compliance to the supervisor
Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the efficiency.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operatesQuality assurance and control #li-pfe
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Posted 30+ days ago
