Testing Engineer with GxP Experience
- Quantum Integrators
- 5 - 10 years
- Pune
- 5 months ago
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Job Description
Role: GxP Manual Functional Tester
Location : Pune/Nagpur (office Location)
Duration: Fulltime
We are seeking a detail-oriented Manual Functional Tester with GxP (Good Practice) experience to support testing activities for CreATE (Clinical Reporting and Trial Execution) and related GxP-regulated applications. The ideal candidate will have a strong background in manual testing within a validated environment, solid understanding of clinical trial systems, and a passion for quality and compliance.
Job Description:
Key Responsibilities:
- Perform manual functional, regression, and user acceptance testing for GxP-compliant systems such as CreATE or similar clinical trial systems.
- Review and analyze business and functional requirements to create detailed test cases and test scripts.
- Execute test cases, record results, and log defects using tools like JIRA, HP ALM, or similar.
- Ensure traceability of requirements to test cases and results.
- Participate in test planning, test execution, and test closure activities as part of the Software Development Life Cycle (SDLC).
- Support validation efforts by generating or reviewing documentation (e.g., test protocols, test summary reports).
- Work closely with business analysts, developers, and QA leads to ensure quality delivery.
- Ensure compliance with 21 CFR Part 11, ICH-GCP, and internal quality policies.
- Participate in audits and inspections, providing required test evidence as needed.
Qualifications:
- Bachelors degree in Computer Science, Life Sciences, or related field.
- 3+ years of manual testing experience in GxP-regulated environments, preferably in the pharmaceutical or biotech industry.
- Experience testing clinical trial systems (e.g., EDC, CTMS, eTMF, or CreATE).
- Strong understanding of SDLC, CSV (Computer System Validation), and regulatory requirements.
- Familiarity with tools like JIRA, Confluence, HP ALM, Veeva Vault, or similar.
- Excellent communication, documentation, and organizational skills.
- ISTQB certification is a plus.
Nice to Have:
- Experience with risk-based testing approaches.
- Understanding of clinical study workflows and documentation.
- Exposure to test automation or scripting tools (basic level acceptable).
Regards
Vibha Patel
vi********l@qu**************s.com
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Engineering - Software & QARole Category: Quality Assurance and TestingRole: Quality Assurance and Testing - OtherEmployement Type: Full timeContact Details:
Company: Quantum IntegratorsLocation(s): Pune
Keyskills: Csv Selenium Gxp Automation Testing Manual Testing Hp Alm
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