Specialist, CDS & SDMS, Validation
Hybrid · Hyderabad, Telangana, India
Job Summary
Specialist, CDS & SDMS Validation role based in Hyderabad. Drafts, edits, and formats SOPs, work instructions, and validation records for the Empower CDS platform, ensuring alignment with GxP and data integrity. Works under guidance to support document management, version control, and regulatory-compliant documentation; collaborates with technical teams to gather information and build domain knowledge of Empower systems and regulated environments. Requires a Bachelor’s degree and 3+ years of software experience, with familiarity in Waters Empower CDS, NuGenesis SDMS, IQ/OQ/PQ, and related validation practices; hybrid work arrangement in a global IT/tech-centered healthcare environment. Describes responsibilities, required skills, and a path to contribute to FDA-compliant documentation and SDLC activities in a medicinal/pharmaceutical setting.
Required Qualifications
- Bachelor's degree or equivalent in Pharmaceutical, Scientific, Technology, Engineering, or Mathematics field
- minimum 1 year in relevant field
- 3+ years of software experience
- Familiarity with SOP, IQ/OQ/PQ, GxP, CSV
- Knowledge of Waters Empower CDS and NuGenesis SDMS preferred
- Strong communication and documentation skills
- English fluency
- GxP and data integrity awareness
- Experience with SDLC and CSA
- Experience in Pharma industry and knowledge of cGMP
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