Senior Specialist, CDS & SDMS, Business Unit
Hybrid · Hyderabad, Telangana, India
Job Summary
Senior Specialist, CDS & SDMS for Waters Empower CDS platform based in Hyderabad. Collaborate with site SMEs and multiple global groups to ensure the system is implemented and sustained in compliance. Work under guidance of the business system owner but independently deliver tasks to meet business needs. Role includes gathering user stories/requirements, driving change and adoption of global processes at a site, and assisting in transforming the system into a fully integrated platform with global ownership of Empower master data as part of the end-to-end digital laboratory solution. Requires experience with Waters Empower CDS and NuGenesis SDMS, SDLC, CSA, GxP, data integrity, and strong stakeholder management, plus excellent communication and documentation skills.
Required Qualifications
- Bachelor's degree or equivalent in Pharmaceutical, Scientific, Technology, Engineering, or Mathematics
- Minimum 1 year making a difference in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field OR 7+ years of related experience
- GxP principles, data integrity, and document control practices
- Strong collaboration and change management skills
- Experience with Waters Empower CDS and NuGenesis SDMS
- Experience with JIRA for planning and demand management
- Knowledge of System Development Lifecycle (SDLC) activities and Computer System Assurance (CSA)
- Experience within a regulated laboratory or directly supporting Laboratory processes
- Experience using Waters Empower CDS and NuGenesis SDMS preferred
- Excellent communication skills and ability to gather information from SMEs
- Fluency in English; ability to work in a global environment
- Experience in Pharma Industry with knowledge of cGMP and Laboratory processes
- Strong analytic, critical thinking and problem-solving skills
Desired Qualifications
- Bachelor's degree or equivalent in Pharmaceutical, Scientific, Technology, Engineering, or Mathematics
- 7+ years of experience in Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics
- GxP principles, data integrity, and document control practices
- Strong collaboration and change management skills
- Experience with Waters Empower CDS and NuGenesis SDMS
- Experience with JIRA for planning and demand management
- Good understanding of System Development Lifecycle (SDLC) and Computer System Assurance (CSA)
- Experience in a regulated laboratory or directly supporting Laboratory processes
- Strong communication and documentation skills; ability to gather information from SMEs and author/ review procedures
- Fluency in English; ability to work in a global, distributed team
- Knowledge of cGMP and Laboratory processes
- Analytical, critical thinking and problem-solving skills
- Attention to detail and self-motivation
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