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Software Engineer

Software Engineer

StrykerGurugram, Haryana, India
12 hours ago
Job description

Work Flexibility : Hybrid

What you will do :

  • Design, develop, and maintain detailed test cases, checklists, and test data; Execute test cases for web, mobile, and desktop applications; Identify, document, and track defects using a bug-tracking tool (e.g., Jira).
  • Perform different types of testing : Functional, Regression, Integration, System, Sanity, etc; Participate in review meetings, sprint planning, and daily stand-ups
  • Develop and execute validation strategies and plans for new and existing computerized systems.
  • Create and maintain validation documents including : User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessment; Validation Plans (VP) ; IQ / OQ / PQ Protocols and Reports; Traceability Matrix.
  • Perform impact assessments and change control activities for validated systems.
  • Provide training and guidance on CSV processes and best practices.
  • Maintain validation documentation in alignment with company procedures and regulatory expectations.

What you will need-

Required :

  • Experience- 2yrs to 5 years of experience in manual software testing and computer system validation within regulated industries (pharma, biotech, medical devices).
  • Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field.
  • Good understanding of SDLC, and defect life cycle; Experience with bug-tracking / project management tools (e.g., Jira, Devops); and validating systems such as Valgenesis, and custom applications.

    • Preferred :

  • Understanding of software development life cycle (SDLC) and risk-based validation approaches; CSV certifications (e.g., ISPE, PDA) or GxP training; ISTQB Certification
  • Experience in data integrity assessments and remediation projects; Familiarity with cloud-based systems and cybersecurity considerations.
  • Strong knowledge of GAMP 5 , 21 CFR Part 11 , Annex 11 .
  • Excellent documentation, reporting, communication, and project management skills.

    • Travel Percentage : None

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    Software Engineer • Gurugram, Haryana, India