Location: India, BengaluruApply Now
As a Consultant in Life Sciences Professional Services team you will work closely with other Professional Service Consultants in the delivery of OpenText Life Sciences engagements (OpenText Documentum for Research and Development, OpenText Documentum for Quality and Manufacturing, OpenText Documentum for eTMF, OpenText Documentum Submission Store and View) and be responsible for creation and execution of OQ scripts, creation of OQ protocols, summary reports and other validation related artifacts.
You are great at:
• Represent Opentext in a professional manner to customers, partners and other Opentext personnel at all times
• Support and report to engagement project manager while assigned to active customer engagements. Ensure that all project communication with the customer goes through the engagement project manager
• Understand requirements, assist in validation related activities. Seek advice or assistance from senior staff as required during difficult customer situations. Work in conjunction with colleagues and the Product Support organization to ensure effective resolution of technical issues encountered during implementations
• Prepare, maintain and submit activity/progress reports and time recording/management reports in accordance with published procedures. Keep project managers informed of activities and alert of any issues promptly
• Provide knowledge transfer to team members throughout and at the completion of assigned projects
• Required to train staff personnel when authorized by management on less complex solutions and adhere to processes and methodologies to perform the required function. Report deviations from defined processes to the engagement project manager and recommend associated improvements
• Acquire Opentext Proven Certification in Documentum Content Management and other life science related certifications
What it takes:
• Must have 5 or more years of recent development experience in Documentum with at least 3 years in validation of LSQM & LSRD. Experience in eTMF and SSV is an added advantage.
• Excellent grasp of Documentum Life Sciences Suite and the value proposition it offers to customers
• Knowledge on Quality & Manufacturing and Regulatory is a must
• Solid understanding & experience in GxP, eCTD, GAMP and delivering validated applications (21 CFR Part 11)
• Knowledge of Regulatory Affairs, RIM, Compliance and Validation, Quality assurance/systems and life sciences and pharmaceutical industry in general.
• Strong planning and analytical skills combined with ability to work with geographically distributed teams in a rapid development model
• Excellent communication skills and an ability to present complex technical topics in a manner non-technical stakeholder can easily understand
At OpenText we understand and value diversity in our employees and are proud to be an Equal Opportunity Employer.