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In Process Quality Assurance - India  

Company managed [?] Still accepting applications

Posted on : 08 March 2017

Project Description


Role
Assistant Manager

Reporting To:
  
Manager -Quality Assurance



Key Responsibilities:  
  • Execute / assign process activities, material verification, start-up of machines and sampling activities to ensure product quality and compliance 
  • Execute / assign execution of batch records, log, fill in the various applicable; batch records review sheets 
  • Review the records maintained by production team and make additional records 
  • Conduct documentation w.r.t. QA activities and check if the documentation is happening online with the manufacturing operations.
  •  In case of deviations follow the incident reporting system to ensure requisite documentation for manufacturing processes is in line with GMP and other regulations 
  • Issue / assign issuance of approved procedures, SOPs to manufacturing team and check if the same are available in the work area and are adhered to by the manufacturing team 
  • Check the quality management system (QMS) elements such as change control, incident management, if CAPA management are adhered to on the shop floor and check if the manufacturing facility (area & process) is meeting the basic GMP requirements (e.g. facility upkeep, environmental conditions, segregation of materials, status labelling etc.) at all times & during manufacturing. In case of deviations follow the incident management process to ensure that the products are manufactured in line with approved systems & procedures 
  • Provide support to supervisor for carrying out investigations related to complaints, batch failures, OOS/ OOT, incidents etc. and collate the data from batch documents, log books and also through interviewing the concerned colleagues involved in that particular activity 
  • Coordinate with cross functional teams to support and drive the investigation process, conduct root cause analysis, document CAPA, check implementation with in the timeline and as per agreement in the specific work area and monitor its effectiveness over a period of time to ensure investigation is carried out in a structured way to avoid repetition of similar incidents / failures in future