IT Quality Assurance

Micro Therapeutic Research Labs Pvt. Ltd (MTRL) is a leading global Clinical Research Organization (CRO) dedicated to advancing public health by supporting the development of new therapies and medical breakthroughs. We partner with pharmaceutical and biotechnology companies to conduct clinical trials worldwide. Our commitment to data integrity, patient safety, and regulatory compliance is paramount. Join us for a hands-on internship where your work will directly contribute to the high standards that bring new treatments to patients.

Internship Overview

We are seeking a highly motivated and detail-oriented final-year college student for an internship within our IT Quality & Compliance team. This role offers a unique opportunity to gain foundational experience in Computer System Validation (CSV) and Quality Assurance within a regulated clinical research environment. You will learn the critical principles of GxP (specifically GCP - Good Clinical Practice) as they apply to computerized systems used in clinical trials.

Key Responsibilities

Under the guidance of experienced QA/QC professionals, you will:

• Learn Regulatory Fundamentals: Understand the importance of CSV in the context of FDA 21 CFR Part 11, EU Annex 11, and GxP regulations.
• Support Validation Activities: Assist in the execution of validation protocols for clinical IT systems (e.g., EDC, CTMS, eTMF).
• Documentation Development: Help draft, review, and organize essential CSV documentation, which may include:
• Requirement Specifications (User Requirements - URS, Functional Requirements - FRS)
• Validation Test Scripts (IQ/OQ/PQ)
• Traceability Matrix
• Test Result Reports
• Validation Summary Reports
• Quality Control Checks: Perform quality control reviews of validation documents to ensure accuracy, clarity, and compliance with company SOPs.
• Testing Support: Assist in the execution of test cases, document results meticulously, and report any anomalies or defects.
• Issue Management: Learn to use tracking systems to log and monitor issues found during testing.
• SOP Training: Read and train on Standard Operating Procedures governing CSV and IT Quality processes.

Who We Are Looking For (Qualifications)

• Currently in the final year of a Bachelor's or Master's degree in Computer Science, Information Technology, Life Sciences, Pharmacy, Biotechnology, or a related field.
• A strong academic record and a keen interest in a career at the intersection of IT, Quality, and Clinical Research.
• Meticulous attention to detail – a non-negotiable skill for QA/QC and compliance work.
• Strong analytical and problem-solving abilities.
• Basic understanding of software development life cycles (SDLC) and software testing concepts is a significant advantage.
• Excellent written and verbal communication skills for precise documentation.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

What You Will Gain

• In-Demand Skills: Acquire hands-on experience in Computer System Validation (CSV), a critical and highly sought-after skill in the pharmaceutical and clinical research industry.
• Industry Knowledge: Learn about GxP regulations and the role of IT in ensuring data integrity and patient safety in clinical trials.
• Professional Mentorship: Receive direct guidance and training from seasoned IT QA professionals.
• Career Launchpad: Build a strong resume with practical, real-world experience that will make you a competitive candidate for full-time roles in CROs and pharma companies.
• Certificate & Reference: Receive a formal internship completion certificate and a potential letter of recommendation based on performance.
• Future Opportunity: Outstanding performers may be considered for full-time positions upon graduation.

How to Apply

Interested candidates who are eager to learn and contribute to the field of clinical research are invited to apply on Indeed with their updated resume/CV.

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Job Types: Full-time, Internship

Contract length: 3 months

Pay: ₹3, ₹5,000.00 per month

Work Location: In person