16 Aug
|
Tata Consultancy Services
|
Pune
16 Aug
Tata Consultancy Services
Pune
Role: CDS EMPOWER Administrator / Application Support
Required Technical Skill Set:
CDS EMPOWER Administrator professional responsible for managing, supporting, configuring, and maintaining Waters Empower Chromatography Data System (CDS) in a regulated GxP workplace. The role ensures system availability, user administration, instrument connectivity, data integrity, compliance, and support for laboratory operations while collaborating with QA, QC, Validation, and IT teams.
Desired Experience Range: 4–6years
Location of Requirement: PAN India
Desired Competencies
Must-Have
Functional
- Strong understanding of Chromatography Data Systems (CDS) and laboratory workflows.
- Experience in Empower Administration and Application Support.
- Knowledge of pharmaceutical QC laboratory processes.
- Experience in Incident, Problem, Change, and Service Request Management.
- Understanding GxP, FDA, ALCOA+, and Data Integrity requirements.
- Experience supporting audit and regulatory inspections.
- Strong stakeholder management and communication skills.
Technical
- Hands-on experience with Waters Empower 3 Administration.
- User, Group, Role, and Privilege Management.
- Instrument integration and node configuration.
- Project creation and management.
- Backup, restore, and disaster recovery support.
- Experience supporting Empower upgrades, patches, and migrations.
- Audit trail review and data integrity monitoring.
- Knowledge of Oracle and SQL databases.
- Experience with Empower Security Management.
- Troubleshooting instrument connectivity and application issues.
- Basic Windows Server administration knowledge.
- Familiarity with Active Directory integration.
Specific Skills and Expertise:
- Strong troubleshooting and root-cause analysis skills.
- Ability to manage multiple priorities and support activities.
- Experience creating SOPs, work instructions, and technical documentation.
- Good understanding of laboratory systems validation.
- Effective collaboration with global teams and vendors.
General
- Strong analytical and problem-solving skills.
- Compliance-focused mindset.
- Attention to detail and accuracy.
- Ability to work independently and in team environments.
- Customer-focused approach with strong communication skills.
Good-to-Have
- Experience in Pharmaceutical/Life Sciences domain.
- Knowledge of Computer System Validation (CSV).
- Understanding 21 CFR Part 11 requirements.
- Exposure to Empower Method Validation and Qualification activities.
- Experience with LIMS, ELN, SDMS, or other laboratory systems.
- Knowledge of ITIL processes.
- Experience supporting cloud or virtualized environments.
- Water Empower certification.
Background
- Bachelor's degree in computer science, Information Technology, Life Sciences, Pharmacy, Chemistry, and related fields.
- 4–6 years of experience in Waters Empower Administration, CDS Support, or Laboratory Informatics Applications.
- Experience in regulated pharmaceutical or biotechnology environments preferred.
Responsibility of / Expectations from the Role
- Provide L2/L3 support for Waters Empower application and infrastructure.
- Manage user accounts, groups, roles, and security permissions.
- Configure and maintain Empower projects and repositories.
- Support instrument integration and connectivity troubleshooting.
- Handle incidents, service requests, and change activities.
- Monitor application of health, performance, and availability.
- Perform backup, restore, and disaster recovery activities.
- Support Empower upgrades, patches, and system migrations.
- Ensure compliance with GxP, 21 CFR Part 11, and Data Integrity requirements.
- Review and maintain audit trails and security controls.
- Prepare and maintain SOPs, validation documents, and support records.
- Coordinate with laboratory users, QA, vendors, and IT teams for issue resolution.
- Support qualification, validation, and periodic review activities.
- Participate in inspections, audits, and compliance assessments.
📌 CDS EMPOWER Administrator / Application Support (Pune)
🏢 Tata Consultancy Services
📍 Pune