Project Role : Business Architect
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 5 year(s) of experience is required
Educational Qualification : 15 years full time education

Summary:
A leadership-oriented Computerized System Validation (CSV) and Computer Software Assurance (CSA) professional responsible for guiding small teams through end-to-end validation activities in a GxP-regulated environment. This role involves acting as the face of the compliance team, developing Standard Operating Procedures (SOPs), ensuring adherence to global regulatory standards (including FDA, EMEA, 21 CFR Part 11, and GAMP5), and actively supporting external regulatory audits.

Roles & Responsibilities:
- Team Leadership & Execution: Guide and manage small teams while actively performing and overseeing project validation activities.
- Representation & Reporting: Act as the primary liaison for the compliance/validation team during internal meetings, taking charge of gathering data and reporting compliance metrics to management.
- Team Mentorship: Coach and mentor team members to guarantee complete understanding and consistent execution of client workflows and project validation targets.
- Regulatory Oversight: Maintain a comprehensive and up-to-date understanding of FDA and other global regulatory guidelines.

Professional & Technical Skills:
- Global Regulatory Knowledge: Deep expertise in Pharmaceutical Regulatory Compliance and CSV/CSA across major regulatory bodies (e.g., FDA, EMEA).
- End-to-End Validation: Comprehensive knowledge of full-cycle CSV within GxP environments, featuring extensive hands-on experience with the V-Model and the complete validation lifecycle for regulated projects.
- Industry Frameworks: Strong grasp of pharmaceutical regulatory mandates, specifically focusing on 21 CFR Part 11 and GAMP5 guidelines.
- Technical Writing: Proven ability to author, develop, and refine Standard Operating Procedures (SOPs) and Work Instructions.
- Documentation Standards: High level of GxP awareness, including strict adherence to Good Documentation Practices (GDP).
- Audit Support: Practical experience preparing for, participating in, and supporting external regulatory audits.
- Communication & Analysis: Exceptional analytical capabilities paired with strong, clear communication skills.
- Leadership & Critical Thinking: Demonstrated leadership qualities combined with effective problem-solving and troubleshooting abilities.
- Ability to collaborate with diverse teams and stakeholders to gather and validate requirements.
- Excellent problem-solving skills to address challenges during process design and implementation.
- Familiarity with regulatory and compliance considerations related to system validation.

Additional Information:
- Degree: Bachelor of Engineering (BE) degree or an equivalent academic credential.
- The candidate should have minimum 7 years of experience
- This position is based at our Chennai office.
- A 15 years full time education is required.

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 

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