R&D IT - Team Member

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.

Business continuity of live applications by providing support.

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.

Ensure smooth functioning of applications, coordinate with IT infra and ensure IT Infrastructure for applications leading to organization productivity.

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 the deployment, monitoring, maintenance, development, upgrade, and support of IT applications.

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.

Maintain and monitor application licenses ensuring license compliance

Responsible for managing application support. Interface between software vendor and user for problem resolution. Support management of business applications implemented to meet the agreed Service Level Agreement.

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.

Skill (Functional & Behavioural):

Project Management - (Knowledge and Proficiency in project management methodologies, Schedule /Cost/ Scope management of project, Ability to manage small/big, simple/Complex projects, Risk Management, Organization and Planning Skills, Resource Planning, Reporting and Status updates)

Technical Knowledge - Understanding and fair knowledge of IT concepts and SDLC, Programming, Databases, IT Infrastructure, Application configurations and technology, good knowledge of project implementation methodologies like Waterfall, Agile etc.

Business Analysis

CSV (Computer System Validation) and Project documentation

IT project implementation end to end

Team and Stakeholder management

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).