(Total Views: 501)
Posted On: 06/14/2019 11:47:13 AM
Post# of 86974
Atef Khezri
Associate Director of Operations Paragon Bioservices Inc. (now part of Catalent)
Formerly
Operations Manager
Merck
August 2015 – March 2019 3 years 8 months
Elkton, Virginia
Merck’s HPV Vaccine Manufacturing Division.
• Responsible for the production coordination of Gardasil®, Human Papillomavirus Quadrivalent Vaccine, Recombinant - homogenization, microfiltration, ultrafiltration, column chromatography, purification, sterile filtration, adjuvant manufacturing, buffers, weigh & dispense and sterile supply.
• Collaborate with Technical Operations, Facility Engineers, and Control Technicians to support production equipment PM’s, calibrations, and validations.
• Responsibilities of production execution, effective administration of personal performance policies and procedures, management of conflict and change, and the identification and implementation of continuous improvement initiatives.
• Support equipment startup, process and area qualification, SOP and training development, and safety, environmental, and quality audits.
• Maintain Right the First Time standard of work.
• Manage, compose, and review departmental quality documents: deviations, CAPA, investigations, batch record approval.
• Utilization of SAP and DeltaV for production operations.
Associate Director of Operations Paragon Bioservices Inc. (now part of Catalent)
Formerly
Operations Manager
Merck
August 2015 – March 2019 3 years 8 months
Elkton, Virginia
Merck’s HPV Vaccine Manufacturing Division.
• Responsible for the production coordination of Gardasil®, Human Papillomavirus Quadrivalent Vaccine, Recombinant - homogenization, microfiltration, ultrafiltration, column chromatography, purification, sterile filtration, adjuvant manufacturing, buffers, weigh & dispense and sterile supply.
• Collaborate with Technical Operations, Facility Engineers, and Control Technicians to support production equipment PM’s, calibrations, and validations.
• Responsibilities of production execution, effective administration of personal performance policies and procedures, management of conflict and change, and the identification and implementation of continuous improvement initiatives.
• Support equipment startup, process and area qualification, SOP and training development, and safety, environmental, and quality audits.
• Maintain Right the First Time standard of work.
• Manage, compose, and review departmental quality documents: deviations, CAPA, investigations, batch record approval.
• Utilization of SAP and DeltaV for production operations.
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