Job Description

We are seeking a skilled Software Developer with strong software development knowledge and experience in preparing User Requirement Specification (URS), Design, and Validation documentation in compliance with GxP / 21 CFR Part 11 or similar regulatory requirements.

The role involves developing and maintaining software applications, ensuring documentation traceability, and supporting validation processes to maintain system compliance and integrity.

Key Responsibilities

Software Development

1. Design, develop, test, and maintain web or desktop applications using appropriate technologies (.NET, PHP, SQL, etc.).

2. Participate in requirement analysis, system design, and code review sessions.

3. Write clean, maintainable, and secure code following software engineering standards.

4. Develop and integrate databases, APIs, and user interfaces as per specifications.

5. Conduct unit testing, debugging, and performance optimization.

6. Collaborate with cross-functional teams including QA, Validation, and IT Compliance.

Documentation & Validation

1. Prepare and review User Requirement Specification (URS) documents based on user inputs and business processes.

2. Develop Functional Design Specification (FDS) and Technical Design Specification (TDS) documents.

3. Prepare Validation documentation such as:

Validation Plan (VP)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

4. Maintain traceability matrix between URS, FDS, and testing documents.

5. Support Software Risk Assessment and Impact Assessment documentation.

6. Perform software testing activities as per validation protocols and record results.

7. Support change control, deviation handling, and audit trail review processes.

8. Ensure all documentation aligns with GAMP 5, CSV (Computer System Validation), and 21 CFR Part 11 requirements.

Required Technical Knowledge

Proficiency in one or more: C#, ASP.NET, PHP, JavaScript, SQL.

Understanding of Object-Oriented Programming (OOP) and design patterns.

Familiarity with web technologies (HTML5, CSS3, Bootstrap, AJAX).

Database & Tools

Experience with MS SQL Server / MySQL - queries, stored procedures, optimization.

Hands-on experience in Visual Studio / VS Code or equivalent IDEs.

Knowledge of version control systems (Git / Bitbucket).

Knowledge of API development, error handling, and exception logging.

Awareness of software security principles (authentication, data integrity, encryption).

Qualification & Experience

Bachelor's degree in computer science, Information Technology, or Engineering.

Minimum 2-4 years of experience in software development.

Experience in preparing URS, validation, and technical documentation is mandatory.

Soft Skills

Strong analytical, problem-solving, and documentation skills.

Good understanding of GxP and data integrity principles (ALCOA+).

Excellent communication and coordination with QA, IT, and process owners.

Attention to detail and ability to work under compliance guidelines.

Added Advantage

Knowledge of GAMP 5, 21 CFR Part 11, and Annex 11 guidelines.

Experience in CSV (Computer System Validation) activities.

Job Types: Full-time, Internship

Pay: From ₹20,000.00 per month