Software Quality & Validation Specialist

Company: Pharmnova Medical Research
Location: G.K.M. Nagar, Perungalathur, Chennai – 600063
Employment Type: Full-time / Part-time / Consultant
Joining: Immediate

About the Role

Pharmnova Medical Research is looking for an experienced Software Quality & Validation Specialist to support the quality, testing, validation and compliance of our software products.

The role will be responsible for ensuring that the application is thoroughly tested, properly documented, validation-ready and prepared for client qualification, audits and regulatory inspections.

Key Responsibilities

- Plan and execute functional, integration, regression and user acceptance testing.
- Develop detailed test cases, test scenarios and test reports.
- Identify, document and track software defects through resolution.
- Prepare and maintain software validation documentation.
- Develop and maintain User Requirements, Functional Requirements, risk assessments and traceability documentation.
- Plan and support Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
- Review software changes and determine appropriate testing and re-validation requirements.
- Maintain testing, validation and quality records throughout the software lifecycle.
- Assess applicable electronic records, electronic signatures, audit trails, access controls and data integrity requirements.
- Support compliance assessment against 21 CFR Part 11 and other applicable regulatory requirements.
- Support GDPR and data privacy compliance assessments.
- Develop or review SOPs, validation protocols,



reports and quality documentation.
- Support client software qualification and vendor assessment activities.
- Prepare documentation and evidence for client audits and regulatory inspections.
- Work closely with developers to identify quality risks and ensure issues are properly resolved.
- Establish a structured software QA and validation framework for the product.
- Support release readiness and provide QA approval/recommendation before production deployment.

Required Experience

- 3+ years of experience in Software QA, Software Testing, Software Validation or Quality Engineering.
- Strong understanding of software testing methodologies and defect management.
- Experience creating test cases, test plans, test reports and traceability documentation.
- Experience with software validation and risk-based testing.
- Good understanding of electronic records, audit trails, access controls and data integrity.
- Knowledge of 21 CFR Part 11 is preferred.
- Experience with Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) is preferred.
- Experience with regulatory compliance, audits or client qualification is preferred.
- Strong documentation and communication skills.




- Ability to work independently and coordinate effectively with software developers and management.
- Immediate joiner or candidate available within 30 days preferred.

Preferred Industry Experience

Experience in any regulated or quality-sensitive workplace will be considered, including:

- Pharmaceutical / Life Sciences
- Healthcare
- Medical Devices
- Clinical Research
- Pharmacovigilance
- Banking / Financial Services
- Other regulated software environments

Pharmacovigilance or life-sciences experience is an advantage but is not mandatory.

Good to Have

- Experience with API testing and database validation.
- Experience with automated testing tools.
- Experience with cloud-based applications.
- Understanding of data privacy and GDPR.
- Experience supporting customer audits or regulatory inspections.
- Experience preparing validation documentation and quality management procedures.

Employment Options

We are open to experienced candidates for full-time, part-time or consulting engagement, depending on the candidate's experience and availability.

This is an immediate requirement. Candidates who can join at short notice will be preferred.

How to Apply

Please apply with your updated CV and briefly mention your experience in software testing, software validation, regulatory compliance, 21 CFR Part 11, IQ/OQ/PQ, audits or quality management.

Pay: ₹400,000.00 - ₹800,000.00 per year

Experience:

- Software QA / Testing / Validation / Quality Engineering: 4 years (Required)

Location:

- Perungalathur, Chennai, Tamil Nadu (Required)

Work Location: In person

📌 Software Quality & Validation Specialist (Perungalathur)
🏢 Pharmnova Medical Research Private
📍 Perungalathur