R&d IT

**Job Summary**

Working as a Project Lead IT with extensive experience in managing IT projects in life science domain. Managing, implementing projects in different verticals of pharma domain and actively involved in computer system validation activities.
- Management and implementation of IT Projects within the constraints of scope, quality, time, and cost. Delivering systems as per agreed requirements and meet customer satisfaction. Compliance of the system with Regulatory guidelines and applicable SOPs.
- Project Management
- IT Applications - Interface between business users and external IT vendors, Stakeholder management,
- Business Analysis -Understanding Business Requirements, facilitating process improvements and suggesting solutions.
- SOW discussion with vendors, System development support, System Implementation and Validation as per applicable policies along with tracking of project timelines.
- Agreement formalization with vendors as per requirement and providing day to day support to the Business users.
- Project budget management and ensuring the project is delivered within scope, quality and cost.

**Areas Of Responsibility**
- Manage projects within the constraints of scope, quality, time, and cost, to deliver specified requirements and meet customer satisfaction
- Project Management for Application Software, preparing business cases, working on project estimation, project plan, resource management, reviews & execution of the project.
- Interact and effectively communicate with functional heads ensuring alignment of IT to organizational goals
- Effectively communicates IT information / challenges to management, colleagues and cross functional stakeholders ensuring better acceptance of IT point of view and policies.
- Handling of issues and conflict resolution.
- Manage finances related to IT Applications, like purchasing, budgeting and budget review. Reduce expenditures.
- Help and groom team members to help them achieve their goals.
- Business Analysis which includes requirements gathering and business process mapping, analysis and improvement/reengineering. Participation in analysis of business processes and user requirements in order to get the solution development through external Vendors/ procurement of software solutions available in market or maintenance and enhancement as per Business requirements. As-is business process mapping and proposing To-be business process through facilitation exercise with business stakeholders.
- Technical knowledge and understanding of solutions implemented. Troubleshooting bugs and issues for the solutions. Also interfacing with internal IT teams and vendors for issue resolution.
- Project Monitoring & Execution. Creates and maintains project schedules, effort estimation, establishing timelines, create and review validation documents, monitoring milestone completion as per requirement, Project status reporting to senior management, etc.
- Monitors project cost and ensure project completion within allocated budget
- Manage project dependencies & client expectations for the successful delivery of the project
- Responsible for implementing validation strategy and creating/getting created required deliverables for solutions implemented. Has knowledge of applicable computer system validation regulations.
- Work to ensure that project deadlines are met as agreed with the stakeholders
- Interact with vendors and Plan activities of the consultant /vendor, track their effort and cost.
- Escalate critical problems/ issues to the manager, management of issues impacting project deadlines and company resources
- Provide support for various Regulatory audits.
- Provide support regarding preparation and maintenance of R&D IT budget.

**Travel Estimate**

30 %

**Job Scope**

**Internal Interactions (within the organization)**

This position interfaces with R&D & Mfg. operations. (Regulatory Affairs, MACR, Procurement and Purchase, Legal, CQA, Plants, Packaging, QA, Purchase, R&D functions etc.). Interfaces with internal IT sub teams.

**External Interactions (outside the organization)**

Software/Hardware vendors, implementation partners from India and outside

**Geographical Scope**

R&D and Global systems

**Financial Accountability (cost/revenue with exclusive authority)**

Responsible for managing the project budget which would be in the range of INR 5- 8 Cr

**Job Requirements**

**Educational Qualification**

Bachelors of Engineering (Computer Science)/

Bachelors or Masters in Pharma/Science Domain/IT/ Engineering with relevant Project management, Business analysis, project execution and leading experience.

Pharma domain IT experience preferred specially R&D, Clinical and Regulatory IT.

**Specific Certification**

Project Management and CSV

PMP Certification is added advantage.

**Experience**

Minimum 5 to 7 year experience. At least 3 years of experience in IT Project management of medium to big enterprise projects. Pharma domain experience is preferred.

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