Lead Consultant

Req id: 5474

Bangalore, KA, IN

OPENTEXT - THE INFORMATION COMPANY

As the Information Company, our mission at OpenText is to create software solutions and deliver services that redefine the future of digital. Be part of a winning team that leads the way in Enterprise Information Management.

Position Summary

Provides technical and consultative assistance on engagements involving implementing the OPENTEXT Documentum Life Sciences suite for our world-wide customers. Interacts with Business Sponsors, Project Managers and other department heads to identify Business Process relevant for delivering the Validation Packages to several pharmaceutical clients. Develops QA standards, methodologies and define the validation strategy to be followed in understanding, documenting and testing the complex business rules

Capable to Lead and managed multiple business critical projects without any supervision and provides assistance and guidance to junior staff members.

Key Responsibilities

Excellent grasp of Documentum Life Sciences Suite, D2 and the value proposition it offers to customers
Extensive experience leading the validation deliverables for all modules of Life Sciences Suite (LSQM, LSRD, eTMF and SSV)
Good understanding & experience in GxP, eCTD, GAMP and delivering validated applications (21 CFR Part 11)
Working knowledge of various flavors of Unix (AIX, Solaris, Linux etc) and Windows operating systems
Developed QA standards, methodologies and defined the validation strategy to be followed in understanding, documenting and testing the complex business rules
Interacted with Business Sponsors, Project Managers and other department heads to identify Business Process relevant for delivering the Validation Packages to the several pharmaceutical clients.
Prepared Master Validation Plan, Test Strategy/Plan, Requirement Traceability Matrix, Test Scripts/Cases, Acceptance Check List, Test Summary Report and Validation Report for several external pharmaceutical client projects
Prepared and Executed Installation Qualification (IQs), Operation Qualification (OQs) and Performance Qualification (PQs) for several pharmaceutical companies
Performed Quality review, internal audits of validation documentation and processes and participate in external client audits.
Defined SOPs and Job aids as per the QA standards to streamline the quality documentation and execution processes
Organized the Team Meetings and provided the Status Report to project stakeholders on weekly basis
Single Point of Contact for all the validation related activities for various business critical applications
Lead and managed multiple business critical projects without any supervision.
Proficient in techniques for performance testing and tuning RDBMS query performance is an added advantage

Competencies / Skills

Lead Consultants with 8-10 years of IT Project experience
Excellent grasp of the principles of Enterprise Content Management systems
Mandatory experience with leading the validation deliverables for all modules of Life Sciences Suite (LSQM, LSRD, eTMF and SSV)
Mandatory experience with preparing Master Validation Plan, Test Strategy/Plan, Requirement Traceability Matrix, Test Scripts/Cases, Acceptance Check List, Test Summary Report and Validation Report for several external pharmaceutical client projects
Well versed in defect management
Desired experience in developing QA standards, methodologies and defined the validation strategy to be followed in understanding, documenting and testing the complex business rules
Strong analytical skills combined with ability to work in a fast-paced environment with geographically distributed teams
Excellent verbal and written communication skills
Good team and interpersonal skills

Experience

8-10+ years

Education

Bachelors in Engineering discipline (or) Bachelors in Science with Masters in Computer Applications

At OpenText we understand and value diversity in our employees and are proud to be an Equal Opportunity Employer.

OPENTEXT - THE INFORMATION COMPANY

Our growing team is mapping the future of Information Management, and we continue to make new discoveries that expand its boundaries. Join us and be part of a winning team, where the opportunities for your career are limitless.

From its innovative start as a research project by University of Waterloo professors in 1991, OpenText has grown into a global company with offices in more than 35 countries. Our high- performance culture has forged our growth and is an excellent fit for people looking to push themselves to learn and do more.

It’s our time to lead, and as part of our team, it will be your time too. Our continued growth will provide you the opportunity to explore, learn and chart an exciting career path while enjoying a good work-life balance.

Perks
If you thrive in a dynamic work environment, there is always a new horizon to explore. We are proud to offer excellent benefits, challenging work and competitive financial rewards.

Benefits
Our employee programs prioritize employees’ well-being and that of their families. We offer a comprehensive benefit plan, education assistance, a wellness/fitness reimbursement and time off to volunteer.

Social events
With offices around the world and flexible work arrangements, OpenText strives to make sure all our employees feel connected. Teamwork extends to our social lives too from local social events to company-wide activities, we want our employees to take time to relax and have fun.

Corporate Citizenship
Corporate Citizenship is more than a program for us, it is engrained in our purpose, impact, and approach to doing business. Through numerous volunteer initiatives, we support education and innovation for global change.

Explore your career and your potential. Become an OpenText Voyager.

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