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Team Member- Quality Control Analyst - India  

Dr.Reddy's (company)


Posted on : 08 March 2017

Project Description



Key Responsibilities: 
In warding of goods receipt
  • Generation of Analytical Report No. based on the requisition from production/ Warehouse; 
  • verification of batch details with the SAP Data and preparation of Record of Analysis (ROA) and taking it forward for sampling and testing; 
  • Raise an incident report to be logged in QA in case of any discrepancy;
  • take necessary Corrective Actions and Preventive actions as outlined post investigation by Production/ QA / QC teams 
  •  In Order to prioritize , organize and cross check the samples.



Sampling of Raw Materials, Finished Goods and Packing Material
  • Ensure cleanliness of sampling tools; Collect solid & liquid raw materials; 
  • packing materials and samples of key starting material  from RM stores and finished goods from finished storage area with the help of production/ stores; 
  • sampling of solvents from tankers;
  •  labeling of all the collected material and store it in a designated place with proper packing condition; 
  • Raise an incident report and log it with QA in case of a discrepancy and take necessary steps to implement the Corrective Actions and Preventive Actions as identified in the investigation  by senior team members In Order To analyze and check the quality of material.



Releasing of Batch
  • Review and cross check the compliance level, specifications and method of Analysis of the analyzed batch; release the reviewed batch in SAP;
  • issue of duly signed COA to production;
  • labeling of the status on the containers (Approved/ Rejected) 
  •  In order to release batch in timelines and to achieve the dispatch target


Management of working standards, reference standards
  • Evaluate high purity material as working standard on periodic basis; 
  • label and preserve in a closed container without any contamination 
  • In Order to check the quality of Plant batches w.r.t. this working standards


Management of reserve samples/ control samples
  • Preserve an equal quantity of samples for 6 months in case of raw materials and intermediates and for 6 yrs in case of finished goods in proper packing conditions and controlled environment; periodically check these samples for the quality attributes and ensure disposal of the reserved samples after completion of the storage time period 
  •   In order to check the quality of actual batch in case of any customer complaints or Regulatory Affairs queries and investigation of OOS & OOT samples


Performance and calibration of Analytical Instruments
  • Periodically check the instruments for their operation, qualification and calibration; 
  • Co-ordinate with service engineers for re-qualification In case of failure of performance or calibration check of any instrument ; 
  • evaluate the impact of failed instruments on previous batches, raise an incident report and log it with QA; 
  • co-ordinate with internal service engineers for any troubleshooting activity;  
  • In Order to ensure that all equipment's in the facility are calibrated and validated as per standards, regulatory guidelines, and manufacturer specifications



Operating Network: 
 Internal: Team Leaders QC, Group Leader QC, Plant Head QC, Team Members in QC, Production, Material Management, RA,QA, AR&D,R&D
External: External Laboratories, Analytical instrument vendors


 Technical Requirements:
 Basic understanding of Pharma industry & Analytical Chemistry
 


Educational & Experience 
B.Sc in Analytical Chemistry with 2 years of work experience in QC


Key Attributes: 
  • Chemistry knowledge; 
  • Instrumental knowledge;
  •  Analytical knowledge, 
  • Communication Skills, 
  • Writing skills



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