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Job Title:  RA- CSR- Cyber- Assistant Manager- Computer System Validation

Job requisition ID ::  851
Date:  Jun 9, 2021
Location:  Pune
Designation:  Assistant Manager
Entity:  DTTILLP

What impact will you make?  

  

Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential 

 

Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential.  

  

The Team  

 

Deloitte helps organizations anticipate and adapt to changes in the regulatory environment, and build better programs and controls to address the wide variety of regulations and regulatory risks. We work with clients and regulators on effective remediation in response to compliance events. 

 

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 

 

Your role as a leader  

  

At Deloitte India, we believe in the importance of leadership at all levels. We expect our people to embrace and live our purpose by challenging themselves to identify issues that are most important for our clients, our people, and for society and make an impact that matters.  

 

In addition to living our purpose, Assistant Manager across our organization: 

 

  • Acts as a role model, embracing and living our purpose and values, and recognizing others for the impact they make  
  • Develops high-performing people and teams through challenging and meaningful opportunities 
  • Delivers exceptional client service; maximizes results and drives high performance from people while fostering collaboration across businesses and borders 
  • Influences clients, teams, and individuals positively, leading by example and establishing confident relationships with increasingly senior people 
  • Understands key objectives for clients and Deloitte, aligns people to objectives and sets priorities and direction 

  

How you’ll grow  

  

At Deloitte, our professional development plan focuses on helping people at every level of their career to identify and use their strengths to do their best work every day. From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to help build world-class skills in addition to hands-on experience in the global, fast-changing business world. From on-the-job learning experiences to formal development programs at Deloitte University, our professionals have a variety of opportunities to continue to grow throughout their career. Explore Deloitte University, The Leadership Center. 

 

  

Benefits  

At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits.  

Learn more about what working at Deloitte can mean for you. 

 

  

Our purpose    

              

Deloitte is led by a purpose: To make an impact that matters.  

 

Every day, Deloitte people are making a real impact in the places they live and work. We pride ourselves on doing not only what is good for clients, but also what is good for our people and the communities in which we live and work—always striving to be an organization that is held up as a role model of quality, integrity, and positive change. 

 Learn more about Deloitte's impact on the world 

 

Recruiter tips  

We want job seekers exploring opportunities at Deloitte to feel prepared and confident. To help you with your interview, we suggest that you do your research: know some background about the organization and the business area you’re applying to.   

Check out recruiting tips from Deloitte professionals.