Lead Consultant

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.  

Opportunity:

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.

You are great at:

• 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

What it takes:

• 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

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