Executive- MQA Downstream

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 either independently or with technical support/inputs from Supervisor, as required. 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 recipe review, sensor challenge tests etc. Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging Perform Daily walkthroughs and report observations to the Supervisor and ensure appropriate closure of those incidents. Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety independently. Review and assessment of equipment alarms and review of quarterly alarm trends. Report any non-compliance to the Supervisor Responsible for assisting manufacturing investigators via. Collection of data, information and technical support and may perform in conducting investigations 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. Experience in handling regulatory, corporate and internal auditors/ inspectors.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, 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 either independently or with technical support/inputs from Supervisor, as required. 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 recipe review, sensor challenge tests etc. Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging Perform Daily walkthroughs and report observations to the Supervisor and ensure appropriate closure of those incidents. Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety independently. Review and assessment of equipment alarms and review of quarterly alarm trends. Report any non-compliance to the Supervisor Responsible for assisting manufacturing investigators via. Collection of data, information and technical support and may perform in conducting investigations 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. Experience in handling regulatory, corporate and internal auditors/ inspectors.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,

Keyskills :
equal employment opportunitycontinuous improvement facilitationbatch recordspatient safetyproduct qualitytechnical supportquality assurance