T&T | Cyber : CST | AM | Third Party Risk Management | Pune

The Team

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

Work youll do
As a part of our Technology & Transformation team,

Support on IT quality systems framework design and implementation
Managing the reviews and assessments for IT quality
Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies
GxP Business process review
Development of integrated GxP and IT compliance
Standard operating procedures and guidelines
GxP and IT compliance assessment
Define the Validation strategy of IT Software and Systems
Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverables, working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development,
Validation testing and deviation management; and working closely with cross-functional project teams.
Ensure 21 CFR Part 11 compliance for Computerized system
Provide User training on CSV and increase awareness about compliance
Responsible for reducing Gaps identified in various GAP/Risk Assessments existing and new computerized systems and providing a remedial action plan for compliance.
Carrying out an Audit of IT systems to ensure regulatory compliance
Manage the specified business/systems requirements, working closely with the designated Project Manager to facilitate the progress of the project Coach/mentor staff and provide technical leadership, as needed


The key skills required are as follows:

IT Quality, Regulatory, Compliance (IT-QRC)
Quality guidelines mentioned by FDA, MHRA, and other regulatory bodies
GxP practices and GAMP5 guidelines.
Computer System Validation of various COTS products like COGNOS, IMPACT, BAELN and other related applications used in pharmaceutical industries
Experience in activities like Business Analysis, Risk Identification, FRS creation and other validation testing deliverables.
Good understanding & practical experience of 21CFR Part 11 and other FDA GxP regulations.



Your potential, unleashed.

Indias impact on the global economy has increased at an exponential rate and Deloitte presents an opportunity to unleash and realise your potential amongst cutting edge leaders, and organisations shaping the future of the region, and indeed, the world beyond.

At Deloitte, your whole self to work, every day. Combine that with our drive to propel with purpose and you have the perfect playground to collaborate, innovate, grow, and make an impact that matters.


The team
Deloitte helps organizations prevent cyberattacks and protect valuable assets. We believe in being secure, vigilant, and resilientnot only by looking at how to prevent and respond to attacks, but at how to manage cyber risk in a way that allows you to unleash new opportunities. Embed cyber risk at the start of strategy development for more effective management of information and technology risks

Your work profile

As a Consultant of our Technology & Transformation team,


Support on IT quality systems framework design and implementation
Managing the reviews and assessments for IT quality
Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies
GxP Business process review
Development of integrated GxP and IT compliance
Standard operating procedures and guidelines
GxP and IT compliance assessment
Define the Validation strategy of IT Software and Systems
Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverables, working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development,
Validation testing and deviation management; and working closely with cross-functional project teams.
Ensure 21 CFR Part 11 compliance for Computerized system
Provide User training on CSV and increase awareness about compliance
Responsible for reducing Gaps identified in various GAP/Risk Assessments existing and new computerized systems and providing a remedial action plan for compliance.
Carrying out an Audit of IT systems to ensure regulatory compliance
Manage the specified business/systems requirements, working closely with the designated Project Manager to facilitate the progress of the project Coach/mentor staff and provide technical leadership, as needed

Skills

IT Quality, Regulatory, Compliance (IT-QRC)
Quality guidelines mentioned by FDA, MHRA, and other regulatory bodies
GxP practices and GAMP5 guidelines.
Computer System Validation of various COTS products like COGNOS, IMPACT, BAELN and other related applications used in pharmaceutical industries
Experience in activities like Business Analysis, Risk Identification, FRS creation and other validation testing deliverables.
Good understanding & practical experience of 21CFR Part 11 and other FDA GxP regulations.




Location and way of working

Base location: Pune
Professional is required to work from office

Additional Skills

Excellent verbal and written communication skills
Experience in consulting domain to handle/manage different clients

Qualifications

B.E.,B.Tech,MCA,MBA,M.Sc,B.Pharm,M.Pharm or similar
Experience range 1 year to 3 years

Your role as a Deloittee

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.

In addition to living our purpose, you must embrace and strive following across our organization


Inspiring - Leading with integrity to build inclusion and motivation
Committed to creating purpose - Creating a sense of vision and purpose
Agile - Achieving high-quality results through collaboration and Team unity
Skilled at building diverse capability - Developing diverse capabilities for the future
Persuasive / Influencing - Persuading and influencing stakeholders
Collaborating - Partnering to build new solutions
Delivering value - Showing commercial acumen
Committed to expanding business - Leveraging new business opportunities
Analytical Acumen - Leveraging data to recommend impactful approach and solutions through the power of analysis and visualization
Effective communication Must be well abled to have well-structured and well-articulated conversations to achieve win-win possibilities
Engagement Management / Delivery Excellence - Effectively managing engagement(s) to ensure timely and proactive execution as well as course correction for

the success of engagement(s)

Managing change - Responding to changing environment with resilience
Managing Quality & Risk - Delivering high quality results and mitigating risks with utmost integrity and precision
Strategic Thinking & Problem Solving - Applying strategic mindset to solve business issues and complex problems
Tech Savvy - Leveraging ethical technology practices to deliver high impact for clients and for Deloitte
Empathetic leadership and inclusivity - creating a safe and thriving environment where everyone's valued for who they are, use empathy to understand others to adapt our behaviours and attitudes to become more inclusive.



How youll grow

Connect for impact

Our exceptional team of professionals across the globe are solving some of the worlds most complex business problems, as well as directly supporting our communities, the planet, and each other. Know more in our Global Impact Report and our India Impact Report.

Empower to lead

You can be a leader irrespective of your career level. Our colleagues are characterised by their ability to inspire, support, and provide opportunities for people to deliver their best and grow both as professionals and human beings. Know more about Deloitte and our One Young World partnership.

Inclusion for all

At Deloitte, people are valued and respected for who they are and are trusted to add value to their clients, teams and communities in a way that reflects their own unique capabilities. Know more about everyday steps that you can take to be more inclusive. At Deloitte, we believe in the unique skills, attitude and potential each and every one of us brings to the table to make an impact that matters.



Drive your career

At Deloitte, you are encouraged to take ownership of your career. We recognise there is no one size fits all career path, and global, cross-business mobility and up / re-skilling are all within the range of possibilities to shape a unique and fulfilling career. Know more about Life at Deloitte.


Everyones welcome entrust your happiness to us

Our workspaces and initiatives are geared towards your 360-degree happiness. This includes specific needs you may have in terms of accessibility, flexibility, safety and security, and caregiving. Heres a glimpse of things that are in store for you.


Interview tips

We want job seekers exploring opportunities at Deloitte to feel prepared, confident and comfortable. To help you with your interview, we suggest that you do your research, know some background about the organisation and the business area youre applying to. Check out recruiting tips from Deloitte professionals.

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At Deloitte, ethics and integrity are fundamental and not negotiable. Wedo not charge any fee or seek any deposits, advance, or money from any career aspirant in relation to our recruitment process. We have not authorized any party or person to collect any money from career aspirants in any form whatsoever for promises of getting jobs in Deloitte or for being considered against roles in Deloitte. We follow a professional recruitment process, provide a fair opportunity to eligible applicants and consider candidates only on merit. No one other than an authorized official of Deloitte is permitted to offer or confirm any job offer from Deloitte. We advise career aspirants to exercise caution.
In this regard, you may refer to a more detailed advisory given on our website at:https://www2.deloitte.com/in/en/careers/advisory-for-career-aspirants.html?icid=wn_