Job Title: T&T | Cyber : CST | Consultant | 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 you’ll 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.
India’s 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 resilient—not 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 you’ll grow
Connect for impact
Our exceptional team of professionals across the globe are solving some of the world’s 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.
Everyone’s 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. Here’s a glimpse of things that are in store for you.
Interview tips
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