ZS - Associate Consultant
4 weeks ago
Validation Associate Consultant : - CSV
ZS is a professional services firm that works side by side with companies to help develop and deliver products that drive customer value and company results. From R&D to portfolio strategy, customer insights, marketing and sales strategy, operations and technology, we leverage our deep industry expertise and leading-edge analytics to create solutions that work in the real world. Our most valuable asset is our people-a fact that's reflected in our values-driven organization in which new perspectives are integral and new ideas are celebrated.
ZSers are passionately committed to helping companies and their customers thrive in industries ranging from healthcare and life sciences, to high-tech, financial services, travel and transportation, and beyond. ZS's India Capability & Expertise Center (CEC) houses more than 60% of ZS people across three offices in New Delhi, Pune and Bengaluru. Our teams work with colleagues across North America, Europe and East Asia to create and deliver real world solutions to the clients who drive our business. The CEC maintains standards of analytical, operational and technological excellence across our capability groups. Together, our collective knowledge enables each ZS team to deliver superior results to our clients.
ZS's Digital & Technology group drives measurable impact to client business performance through technology-enabled products and solutions, and consistent best-in-class delivery, at a global scale.
ZS's Digital and Technology practice success is driven by collaborating with our domain practices and client teams to embed digital and technology assets and innovations in their services and helping them create a harmonized and distinct ZS technology experience for our clients.
ZS's Testing & QA Expertise Center Group brings deep specialization across niche technologies with skills to play as hands-on tester and automation architect/designer roles. Team members will be expected to rapidly learn new automation technologies and become experts with industry certified credentials.
ZS' R&D Excellence Practice brings together experts in Strategy, Clinical Execution, Data Sciences and Technology to empower client organizations achieve their passion for patient care, science and business success. Through our "Lifecycle Evidence Strategy", "Clinical Trial Optimization", "Medical Affairs" and "Real World Evidence" services, we deliver impact where it matters, from early drug development to commercialization. This role will be aligned with ZS R&D Excellence Practice Area supporting our Technology and Platform services across multiple clients.
TEST ASSOCIATE CONSULANT :
The QA & Test team participates in the Validation Strategy for the overall project, review the Computer System Validation deliverables, develops and executes test cases on software solutions to ensure new functionality and fix known defects. Test Consultants design, implement, test and deploy business intelligence solutions to meet business process :
- Contribute to project's overall Computer System Validation deliverables.
- Create and execute test scenarios; select the best testing methodologies, techniques and evaluation criteria for testing.
- Draft, review and approve validation deliverables such as user requirements, technical design specifications, IQ/OQ/PQ scripts and reports, error logs, configuration document, traceability matrix and document 21 CFR Part 11 and EU Annex 11 compliance.
- Build automation scripts and help the leads in the designing/configuring the test automation frameworks.
- Understand the various testing activities : Unit, System, Component, User Acceptance, Performance, Integration and Regression.
- Participate in user story mapping, sprint planning, estimation, and feature walk-throughs.
- Experience in leading junior test analysts, assigning and tracking tasks provided to team members.
- Manage end to end testing / validation lifecycle on applications likes - Solution Manager, JIRA, and HP ALM (desired).
- Self - motivated, team-oriented individual with strong problem-solving abilities
- Evaluate risks, assess closure requirements, and process change controls for computerized systems.
- Define key test processes, best practices, KPIs, collateral.
- Well verse with ETL or automation testing.
Qualifications :
- Bachelor's/master's degree in engineering, Science, Medical or related field.
- Hands-on experience in Computer System Validation of Applications and Infrastructure.
- A minimum of 3.5-6 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)).
- Experience in managing and leading testing related activities.
- Experience in creating test scenarios and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC or Agile phases as per the standard GxP protocol.
- Hands-on experience on ETL/DW/BI/Automation platform.
- SQL skills for development of expected results and troubleshooting problems found during testing
- In-depth understanding of defect management processes.
- Strong SQL skills for data validation and development of expected results.
- Hands on Test Management Tool - JIRA and HP ALM.
- Experience in defining risk-based strategies for validation of computerized systems and author review end-to-end CSV documentation in accordance with various test plans.
- Understanding CSV and project related SOP's and WI's. Well versed in Good Documentation Practices.
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