Computer System Validation (CSV) Expert – Tenthpin Solutions (all genders) (Any location in India, preferably Hyderabad)

*This role can be based in any location of the above-mentioned employment location. You must be an official resident in the employment country to be considered for this role.

Tenthpin Solutions is looking for an experienced, pro-active and highly skilled CSV Expert to join our rapidly growing organization. The successful applicant will have a passion for creating innovative solutions that add substantial value to our clients and will contribute to our reputation as one of the recent success stories within the Consulting and Technology industry.

The opportunity:

As a CSV Expert you will play a key role ensuring that our software products are qualified in accordance with our quality management system. You will be involved in the development and delivery of cutting-edge software solutions for life science companies with your primary responsibility being to ensure that our software meets quality and regulatory standards. Specifically, you will:
•    Develop and Implement CSV Strategies: define qualifications approaches, including quality plans, test protocols, and risk assessments in compliance with GxP requirements.
•    Support GxP & HIPAA Compliance: ensure product development and lifecycle activities adhere to regulatory standards such as FDA, EMA, HIPAA, and other relevant guidelines.
•    Ensure Data Security & Integrity: oversee compliance with HIPAA regulations related to electronic Protected Health Information (ePHI), access controls, encryption, and audit logging within validated systems.
•    Oversee Qualification Processes and Document Qualification Activities: coordinate and lead qualification activities across our applications, while ensuring that all qualification documentation is complete, accurate, and audit ready.
•    Risk Management: develop risk management processes and ensure mitigation of risks related to system failures or non-compliance with GxP and HIPAA standards.
•    Facilitate Audits and Inspections: prepare for and support internal and external audits, ensuring applications and processes remain compliant and ready for regulatory scrutiny.
•    Maintain Compliance in Change Control: ensure proper qualification and documentation for system changes, upgrades, or migrations, aligning with GxP and HIPAA regulatory requirements.
•    Continuous Improvement: recommend and implement improvements across the product lifecycle process to enhance efficiency and compliance.

What you bring with you:

•    You have successfully completed studies in the field of computer science, engineering or a related field.
•    You are passionate about ensuring compliance and quality in software solutions tailored for the life sciences industry.
•    You have minimum of 5 years’ proven experience in the field of CSV / GxP, ideally at a software supplier for the regulated industry.
•    You have a deep understanding of GxP regulations (such as FDA 21 CFR Part 11, Annex 11, GAMP 5), and HIPAA requirements for handling and securing health-related data.
•    Strong knowledge of data integrity principles (ALCOA+) and security best practices in validated environments. 
•    You are familiar with risk-based approaches and have a solid understanding of risk management practices in regulated environments.
•    Experience in preparing, and supporting regulatory audits and inspections, with an emphasis on CSV, GxP, and data privacy regulations such as HIPAA. 
•    You have a problem-solving mindset with strong analytical skills allowing you to identify and address compliance risk and process improvements.
•    You have a high attention to detail to ensure compliance and qualification accuracy.
•    You are proactive, you value collaboration & teamwork, and you communicate excellently.
•    Fluent in English, any additional language is a plus

Why Tenthpin Solutions

Tenthpin is a leading global consulting and technology boutique for the Life Sciences industry, operating in 8 countries with +400 Consultants and constantly growing. One of our recent announcements was the creation our own product company, Tenthpin Solutions, addressing the business challenges of the Life Sciences industry with innovative software solutions.

Our consultants are passionate and proud contributors to the growth of an exceptional organization, operating globally with the biggest and most exciting brands in the sector to deliver real value.

We are proud to be an organisation where:

• Our workplace values expertise and dedication to deliver exceptional SAP solutions.
• Your ideas matter, and innovation is encouraged. It takes a supportive team to achieve the best results.
• Everyone is part of a truly global team, working with colleagues from all over the world, with diverse backgrounds and cultures.

We offer a competitive salary, benefits package, and an exceptional work environment with long-term career development opportunities.

We look forward to hearing from you.

Tenthpin and Tenthpin Solutions are equal opportunities employers.