Rahman Anisur

Preparation of SMF,VMP,Quality Manual, EMP,CVMP,Biosafety manual, Master formula of Vaccine Perform Process simulation study (Media fill) for Vaccine manufacturing, Sterile, Cephalosporins. Vendor Approval and Disqualification System, qualification od visual inspector  Quality Risk Analysis Perticipation in performance qualification of different equipments involved in Vaccine manufacturing, Solid doses, Sterile, Infusions area. Responsible for assuring that manufacturing operations are performed in compliance with cGMP as well as with company standards. Implementing and maintaining the quality system conducting personnel training, controlling product design, controlling documentation, product identification and traceability at all stages of production, controlling and defining production and process, defining and controlling inspection. GMP compliance: Scheduling and execution of Internal Audit for systematic investigation of discrepancies in an attempt to prevent their recurrence (Corrective Action) or prevent from occurrence (Preventive Action). Increase the quality consciousness of the employees. Product complaint handling: analyze quality deviation and failures, takes steps to prevent quality problems like extra controls and process improvements through CAPA. Change control management. Documentation of product release and assure timely archiving of documents. Carry out the procedure and documentation for process validation. Analysis and Reporting Annual Product Quality Review Reviewing the whole batch and all analysis documents for batch release. Handling of Quality Incident Report (QIR) or deviation Ability to design training manual and manage training program in the area of GMP Basic GMP,Safety,Cleaning & sanitation, Hygiene, Change control, Deviation,sterile mfg,audit preparation, process validation etc. GMP, Safety and on the job training.