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Job Title:  RA- Cyber-AM-CSV

Job requisition ID ::  4145
Date:  Nov 5, 2021
Location:  Delhi
Designation:  Assistant Manager
Entity:  Deloitte Touche Tohmatsu India LLP

Work you’ll do   

As a part of our Risk Advisory team you’ll build and nurture positive working relationships with teams and clients with the intention to exceed client expectations. You’ll:   

  • Involved into Validation of Software Applications, Computer systems. 
  • Involved in GxP Analysis, Gap Assessment, ERES Assessment 
  • Involved in Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC) and Testing methodologies. 
  • Involved in Software Quality Assurance and Risk Management. 
  • Involved in review of GAMP Guidelines  
  • Ensuring that  the entire project life cycle phases are compliant with Clients SDLC  methodology Reporting Compliance status to Global leadership 
  • Understand and ensure applicability of Computer System Validations for the complex change management environment as operating in regulatory compliance framework. 
  • Knowledge of 21 CFR Part 11 of USFDA, EU Annexure 11 
  • Experience in FDA regulated environment with good understanding of cGxP. 
  • Involved in assessments for GxP relevance and for 21 CFR Part 11 like ERES 
  • Coordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems 
  • Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes 
  • Support and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state 
  • Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management 

       

The key skills required are as follows:  

  • Should have completed at least two end to end computer validation projects 
  • Experience in regulations such as 21 CFR Part 11 and Annexure 11 
  • Experience in GAMP 5 
  • A background on Quality systems such as CMMi or ISO 
  • Proven track record in validation and qualification of complex computer systems 
  • Demonstrable knowledge of GxP environs such as cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards 

       

  Qualifications   

   

  • B.E./B.Tech./MCA/MBA/M.Sc/B.Pharm/M.Pharm 
  • Professional Qualification - Computer System Validation 
  • Experience - 5-7 Years