Project Role Description : Identify opportunities to deliver tangible business value by assessing the current state, capturing high-level requirements, and defining business solutions. Translate business needs into technology-enabled solutions and operating models. Support transformation by developing business cases and guiding implementation of key initiatives.
Must have skills : Computer System Validation (CSV)
Good to have skills : NA
Minimum 18 year(s) of experience is required
Educational Qualification : 15 years full time education
Key Responsibilities
a: Pharma Regulatory Compliance and CSV/CSA
b: End-to-End CSV in GxP environment with deep experience in validation life cycle and V-Model
c: Good understanding of Pharma Regulatory requirements including CFR Part 11 and GAMP5 guidelines
d: Ability to make decisions independently and to resolve issues appropriately to achieve a desired result or impact
e. Ability to provide GxP validation strategy for the overall program.
Technical Experience
a: Experience with at least one of the below: - Cloud Computing/Qualification - Using AI in the regulated environment - SAP validation
b: Experience with pre-sales and solutioning/estimation
c: Agile Methodology and Supplier Assessments
d: Experience in facing regulatory/ client audits, conducting internal audits, experience in risk management
e. General understanding of current technological trends and its use cases in healthcare domain.
Professional Attributes
a: Published thought leadership papers/speaker at external seminars
b: Leadership and problem-solving Skills
d: Strong analytical, communication skills
e: Excellent oral and written communication skills
Educational Qualification
BE or equivalent completed
Additional Information
CSV, Validation, 21 CFR Part 11 and computerized system validation
15 years full time education
About Accenture
Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.Visit us at www.accenture.com
Equal Employment Opportunity Statement
We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, military veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicable law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
Skills Required
- At least 18 years of professional experience
- 15 years of full-time education
- Bachelor of Engineering or equivalent degree
- Computer System Validation (CSV) experience
- End-to-end CSV experience in a GxP environment
- Deep experience with validation life cycle and V-Model
- Understanding of pharma regulatory requirements, including 21 CFR Part 11 and GAMP5
- Experience with cloud computing qualification, AI in regulated environments, or SAP validation
- Experience with pre-sales and solutioning or estimation
- Experience with Agile methodology and supplier assessments
- Experience facing regulatory or client audits and conducting internal audits
- Experience in risk management
- Ability to provide GxP validation strategy for an overall program
- Strong leadership, problem-solving, analytical, oral, and written communication skills
- Published thought leadership papers or experience speaking at external seminars
Accenture Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Accenture and has not been reviewed or approved by Accenture.
-
Healthcare Strength — Pay is considered competitive when paired with robust insurance options and other perks that compare well with large consulting and IT services peers. Multiple national medical plan options plus dental and vision are positioned as a core strength of the overall package.
-
Retirement Support — Retirement support is positioned as a standout feature through a 401(k) dollar-for-dollar match up to a set percentage after eligibility. The package is reinforced by additional financial programs such as savings tools and related resources.
-
Parental & Family Support — Parental and caregiving supports are presented as a meaningful benefit differentiator through substantial paid parental leave and multiple caregiver-oriented programs. Backup care and fertility/adoption/surrogacy navigation and reimbursements add breadth to family support beyond leave alone.
Accenture Insights
What We Do
Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Interactive, Technology and Operations services—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 500,000+ people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities. Visit us at www.accenture.com.
