Test Manager

Posted 6 Days Ago
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Pune, Mahārāshtra
In-Office
Expert/Leader
Cloud • Information Technology • Consulting • Cybersecurity • Big Data Analytics
Lets Power Higher Performance
The Role
Lead validation and testing for clinical-trial web applications: define test strategies, create validation documentation (VMP, IQ/OQ/PQ), implement risk-based testing (GAMP 5), manage UAT and stakeholder coordination, lead test teams, ensure GxP and 21 CFR Part 11 compliance, oversee functional/integration/performance testing, and maintain traceability, CAPA, and reporting.
Summary Generated by Built In
Company Description

T-Systems Information and Communication Technology India Private Limited (T-Systems ICT India Pvt. Ltd.) is a proud recipient of the prestigious Great Place To Work® Certification™. As a wholly owned subsidiary of T-Systems International GmbH, T-Systems India operates across Pune, Bangalore, and Nagpur, boasting a dedicated team of 3500+ employees providing services to group customers. T-Systems offers integrated end-to-end IT solutions, driving the digital transformation of companies in all industries, including automotive, manufacturing, logistics, and transportation, as well as healthcare and the public sector. T-Systems develops vertical, company-specific software solutions for these sectors. T-Systems International GmbH is an information technology and digital transformation company with a presence in over 20 countries and a revenue of more than €4 billion. T-Systems is a world-leading provider of digital services and has over 20 years of experience in the transformation and management of IT systems. As a subsidiary of Deutsche Telekom and a market leader in Germany, T-Systems International offers secure, integrated information technology and digital solutions from a single source.

Job Description

Experience    9 to 12 years

  • Develop and implement comprehensive test strategies for clinical trial web applications
  •   Create validation master plans  VMP  and validation protocols in accordance with GXP requirements
  •   Define test approach for different validation phases  IQ  OQ  PQ
  •   Establish risk based testing methodologies aligned with GAMP 5 principles
  •   Plan and coordinate User Acceptance Testing  UAT  with clinical stakeholders
  • Team Leadership   Management
  •   Lead and mentor a team of test engineers and validation specialists
  •   Assign tasks and monitor team performance against project timelines
  •   Conduct regular team meetings and provide technical guidance
  •   Foster collaboration between testing  development  and quality assurance teams
  •   Manage resource allocation and capacity planning
  • Compliance   Quality Assurance
  •   Ensure all testing activities comply with GXP  GCP  GLP  GMP   GDP  and GAMP guidelines
  •   Maintain traceability matrices linking requirements to test cases and defects
  •   Review and approve validation documentation including test plans  protocols  and reports
  •   Coordinate with QA teams for regulatory inspections and audits
  •   Implement and maintain quality metrics and KPIs
  • Technical Testing Activities
  •   Oversee functional  integration  system  and performance testing
  •   Validate data integrity  security  and audit trail functionality
  •   Ensure proper testing of electronic signatures and 21 CFR Part 11 compliance
  •   Coordinate testing of system interfaces and data migrations
  •   Manage testing environments and test data provisioning
  • Documentation   Reporting
  •   Create and maintain comprehensive test documentation
  •   Generate validation summary reports and executive dashboards
  •   Document deviations  CAPAs  Corrective and Preventive Actions   and change controls
  •   Ensure proper version control and document management
  •   Provide regular status reports to stakeholders and senior management
  • Stakeholder Management
  •   Collaborate with clinical operations  data management  and biostatistics teams
  •   Interface with regulatory affairs and quality assurance departments
  •   Coordinate with vendors and third party service providers
  •   Present testing results and validation status to executive leadership

Additional Information

Please Note: Fraudulent job postings/job scams are increasingly common. Beware of misleading advertisements and fraudulent communication issuing 'offer letters' on behalf of T-Systems in exchange for a fee. Please look for an authentic T-Systems email id - [email protected].

Stay vigilant. Protect yourself from recruitment fraud!

To know more please visit : Fraud Alert

Top Skills

Gamp 5,Gxp,Gcp,Glp,Gmp,Gdp,21 Cfr Part 11,Validation Master Plan (Vmp),Iq,Oq,Pq,User Acceptance Testing (Uat),Capa,Traceability Matrix
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The Company
HQ: Pune , Maharashtra
3,408 Employees
Year Founded: 2016

What We Do

T-Systems Information and Communication Technology India Private Limited (T-Systems ICT India Pvt. Ltd.) is a certified Great Place To Work®, proudly recognized for its strong people-first culture and commitment to employee excellence.
As a wholly owned subsidiary of T-Systems International GmbH, T-Systems India operates out of Pune and Bangalore, with a dynamic team of over 4,200 professionals delivering high-value IT services to group customers worldwide. T-Systems India plays a key role in this global vision by delivering integrated, end-to-end IT solutions and sector-specific software to drive transformation across industries, including automotive, manufacturing, logistics, transportation, healthcare, and the public sector.

For over 25 years, T-Systems International GmbH has been at the forefront of digital innovation, driving progress and fostering digital optimism. As a leading European IT services provider and a proud part of Deutsche Telekom, T-Systems delivers transformative digitalization projects backed by deep expertise in consulting, cloud, AI, cybersecurity, and connectivity. With a global workforce of 26,000 employees across 26 countries, we set industry benchmarks in efficiency, sovereignty, security, and reliability—empowering organizations to unlock their full digital potential. With annual revenues exceeding EUR 4.0 billion (2024), T-Systems stands as one of Europe’s foremost digital transformation partners, committed to shaping the future of enterprise technology.

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