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+ 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 viz. sensor 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 operates.

Quality Assurance and Control

Posted: 2021-06-04 Expires: 2021-07-05
Sponsored by:
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