Software Engineer

Gurgaon - India

Yearly Salary: INR 2 - 2

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

What you will do:

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 Assessments; Validation Plans (VP); IQ/OQ/PQ Protocols and Reports; Traceability Matrix
Ensure compliance with FDA regulations EMA guidelines and GAMP 5 standards.
Collaborate with IT Quality Assurance Manufacturing and other stakeholders to ensure system functionality meets business and regulatory needs.
Perform impact assessments and change control activities for validated systems.
Support data integrity initiatives and ensure systems comply with 21 CFR Part 11 requirements and provide training and guidance on CSV processes and best practices.
Maintain validation documentation in alignment with company procedures and regulatory expectations.
Develop review and execute detailed test plans test cases and test scripts based on system requirements and design documents.
Perform functional integration regression and user acceptance testing (UAT) across various systems and platforms. Identify document and track defects through resolution using defect management tools (e.g. JIRA HP ALM Bugzilla). Analyze test results generate test reports and provide insights for continuous improvement of the software and testing process

What you will need-

Required:

Bachelors degree in engineering Computer Science Life Sciences or related field.
Experience - 2 years to 5 years
Experience with validating systems such as LIMS MES ERP QMS SCADA PLCs and custom applications.; with test management tools (e.g. JIRA HP ALM TestRail); Exposure to automated testing tools (e.g. Selenium QTP/UFT Postman); Strong knowledge of GAMP 5 21 CFR Part 11 Annex 11.
Understanding of software development life cycle (SDLC) and risk-based validation approaches.
Excellent documentation communication and project management skills.

Preferred :

CSV certifications (e.g. ISPE PDA) or GxP training.
Experience in data integrity assessments and remediation projects.
Familiarity with cloud-based systems and cybersecurity considerations.

Travel Percentage: None

Work Flexibility: HybridWhat you will do: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 Assessments; Validation Plans (VP); ...

Work Flexibility: Hybrid

What you will do:

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 Assessments; Validation Plans (VP); IQ/OQ/PQ Protocols and Reports; Traceability Matrix
Ensure compliance with FDA regulations EMA guidelines and GAMP 5 standards.
Collaborate with IT Quality Assurance Manufacturing and other stakeholders to ensure system functionality meets business and regulatory needs.
Perform impact assessments and change control activities for validated systems.
Support data integrity initiatives and ensure systems comply with 21 CFR Part 11 requirements and provide training and guidance on CSV processes and best practices.
Maintain validation documentation in alignment with company procedures and regulatory expectations.
Develop review and execute detailed test plans test cases and test scripts based on system requirements and design documents.
Perform functional integration regression and user acceptance testing (UAT) across various systems and platforms. Identify document and track defects through resolution using defect management tools (e.g. JIRA HP ALM Bugzilla). Analyze test results generate test reports and provide insights for continuous improvement of the software and testing process

What you will need-

Required:

Bachelors degree in engineering Computer Science Life Sciences or related field.
Experience - 2 years to 5 years
Experience with validating systems such as LIMS MES ERP QMS SCADA PLCs and custom applications.; with test management tools (e.g. JIRA HP ALM TestRail); Exposure to automated testing tools (e.g. Selenium QTP/UFT Postman); Strong knowledge of GAMP 5 21 CFR Part 11 Annex 11.
Understanding of software development life cycle (SDLC) and risk-based validation approaches.
Excellent documentation communication and project management skills.

Preferred :

CSV certifications (e.g. ISPE PDA) or GxP training.
Experience in data integrity assessments and remediation projects.
Familiarity with cloud-based systems and cybersecurity considerations.

Travel Percentage: None

Key Skills

Spring
.NET
C/C++
Go
React
OOP
C#
Data Structures
JavaScript
Software Development
Java
Distributed Systems

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About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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