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
7.5 year(s) of experience is required
Educational Qualification : 15 years full time education
Summary:
A senior leadership-driven Computerized System Validation (CSV) and Computer Software Assurance (CSA) professional responsible for directing overall project validation activities in a GxP-regulated environment. This role involves leading validation teams, acting as the primary compliance representative for client and internal meetings, managing complex regulatory audits, and ensuring strict adherence to global regulatory standards (including FDA, EMEA, 21 CFR Part 11, and GAMP5) utilizing modern methodologies and tools like Agile, SAP, and Cloud platforms.
Roles & Responsibilities:
- Team Leadership & Execution: Lead validation teams and definitively drive overall project validation activities from initiation to successful delivery.
- Representation & Reporting: Represent the compliance/validation team in both internal and client-facing meetings, actively reporting key performance and compliance metrics to senior management.
- Team Mentorship: Coach and mentor team members to guarantee complete understanding and consistent execution of client workflows and validation objectives.
- Stakeholder Management: Develop, foster, and maintain highly effective and collaborative relationships with clients and cross-functional stakeholders.
- Audit Management: Actively participate in and face regulatory and client audits, while also taking charge of conducting internal compliance audits.
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.
- Tools & Methodologies: Extensive practical experience working with modern methods, technologies, and tools including Agile frameworks, Cloud-based environments, SAP, HP ALM, and ServiceNow.
- Autonomous Decision-Making: Proven ability to make critical decisions independently and resolve complex issues effectively to achieve desired project impacts.
- Communication & Analysis: Exceptional analytical capabilities paired with strong, clear communication skills.
- Leadership & Critical Thinking: Demonstrated leadership qualities combined with exceptional problem-solving and troubleshooting abilities.
Additional Information: -
- Degree: Bachelor of Engineering (BE) degree or an equivalent academic credential.
- The candidate should have a minimum of 9 -12 years of experience.
- This position is based at our Bangalore office.
- A 15 years full time education is required.
