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Executive- Production Systems - India  

Dr.Reddy's (company)

Posted on : 08 March 2017

Project Description

 Key Responsibilities: 
  •  Collect and review all executed BPRs / BCRs with PR, TI & ATR sheets
  •  Submit reviewed BPRs to IPQA and resolve observations given by IPQA;
  •  Submit IPQA reviewed BPRs to QA to ensure adequate and accurate documentation of the executed batches within timelines
  •  Preparation of Change list for equipment / Process. Initiation, daily checking, tracking and timely closure of CCFs in the SAP
  •  Coordinate with QA to assign the CCF to cross functional teams; Prepare validation documents like BPR, Protocol, Process flow and layouts
  •  Raise Incidents related to OOS / OOT through SAP
  •  Prepare the investigation reports for General IRs in coordination with cross functional teams;
  •  Track CAPA; Ensure Closure of IR before dispatch in order to close any deviations
  •  Online review of Documents prior to Audit to meet the cGMP compliance;
  •  Support RA in the DMF filling: Prepare Process description, Process flow, Equipment list and Equipment layout; Prepare SOP's with the help of operating people / System executive; 
  • Prepare Equipment Performance qualifications after completion of IQ and OQ in order to meet the requirement of quality systems. 

Operating Network: 
  • Area Head-Production ,
  • Manager-Production, 
  • Manager-Process Engineering,
  • Team Leader  Production Systems, 
  • Shift Supervisor-Production, Shift Chemist-Production 

Technical Requirements:
Good Understanding of the Pharma Industry.

Educational & Experience: 
  • BSc with experience of 3- 7 years. 
  • (Experience in production operations, documentation operations) 

Key Attributes: 
  • Guidelines & SOP's, 
  • Equipment, 
  • process knowledge, 
  • SAP knowledge related to production module, 
  • Communication, People

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