Specialist, CDS & SDMS, Validation

Overview

Support technical documentation and validation activities for the Waters Empower CDS and NuGenesis SDMS platforms in a regulated pharmaceutical environment.

What you'll do

• Draft, edit, and format SOPs, work instructions, and validation records.
• Follow templates, version control processes, and internal documentation standards.
• Support Computer System Validation and Computer System Assurance activities.
• Gather information from subject matter experts and incorporate feedback.
• Apply SDLC practices to documentation and system activities.
• Use testing tools and methods such as JIRA and Microsoft Teams.
• Maintain documentation aligned with GxP and data integrity requirements.

What you'll need

• Bachelor's degree or equivalent.
• At least 1 year in a pharmaceutical, scientific, technology, engineering, or mathematics field.
• At least 3 years of software experience.
• Knowledge of SOPs, IQ/OQ/PQ, GxP, and Computer System Validation.
• Understanding of data integrity and document control practices.
• Knowledge of cGMP and laboratory processes.
• Strong communication, analytical, critical-thinking, and problem-solving skills.

Nice to have

• Experience with Waters Empower CDS and NuGenesis SDMS.

Details

• Location: Hyderabad, Telangana, India.
• Work arrangement: Hybrid.
• Employee status: Regular.