Pranay S.
Quality Control Associate at Tata Consultancy Services
- Role
- Quality Control Associate at Tata Consultancy Services
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Pranay S.
Extremely Motivated and hard working, looking forward to work in direction of the company\'s goals and growing myself along with them.
Experience
Quality Control Associate
Apr 2021 — Present · IN
Clinical Data Management | EDC Validation | Senior QCAClinical Data Management professional with strong hands-on experience in EDC Validation, Edit Check Testing, SAS QC, and audit-ready CDM deliverables for global clinical trials. Proven expertise in ensuring data quality, regulatory compliance, and timely delivery in alignment with ICH-GCP, SOPs, and client SLAs.EDC Validation & QC• Created and documented Data Validation Specifications (DVS) with detailed validation scenarios and expected results• Executed end-to-end EDC validation by entering test data, validating actual vs expected outcomes, and re-testing failed checks.• Testing (Creation/TCC, Data- Entry & Execution/Validation) SAS Edit checks, Dynamic checks, iMedidata Rave SAS, EDC validation, InForm and Veeva CDB.• Documented validation issues, updated DVS, and re-executed testing following programming updates• Collaborated with CDM, Programming, and Study teams to resolve logic gaps and ensure complete validation coverageDSUR:• Supported DSUR activities, including programming setup, QCA validation, append support, and final QC reviewQuality, Compliance & Delivery• Ensured deliverables met TCS quality standards, regulatory expectations, and agreed SLAs• Supported internal and client audits, maintaining audit readiness and timely closure of observations• Maintained strong documentation, traceability, and compliance across QC activitiesTools & Skills• EDC: Rave, InForm, Veeva CDB, iMediData• Programming: SAS 9.4, Base SAS• Technical: SQL, PL/SQL (basic), Linux exposureRecognized for high-quality delivery, attention to detail, mentoring junior team members, and effective stakeholder coordination.
Education
Maharashtra State Board of Technical Education, Mumbai
High School Diploma
Mumbai University
Bachelor of Science
Manipal University Jaipur
Master's Degree
Manisha Education Trusts Smt. Janakibai Rama Salvi College of Arts Commerce & Science
Bachelor of Science, Information Technology
2014 — 2018
Shivai Junior College
HSC, Science
2012 — 2014
Shri Harkrishan English High School
SSC
2000 — 2012
Manipal University Jaipur
Master of Computer Applications - MCA
Shivai Enterprises - India
H.S.C: Science
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