Role description

Job Title: Senior Specialist - Quality Engineering

Location: Bangalore

Experience: 8-12 years

We are seeking a highly experienced Senior Specialist in Quality Engineering with a strong background in Computer System Validation for our Bangalore team. This role is critical for ensuring the quality and compliance of our life sciences applications through robust testing and validation processes.

Job Description:

1. Lead and execute Computer System Validation (CSV) activities for life sciences applications, ensuring adherence to regulatory standards.

2. Oversee Quality Assurance Software Testing activities, from planning to execution and reporting.

3. Develop and optimize IT processes to ensure compliance with relevant regulations and industry standards, including GxP and 21 CFR Part 11.

4. Manage the end-to-end validation process, including the creation of Validation Plans, Reports, and Installation Qualification baselines.

5. Collaborate with project and integration management teams to drive quality throughout application development and maintenance projects.

6. Track, review, and approve all quality deliverables, ensuring accuracy and completeness.

7. Support internal and external audit management activities, providing necessary documentation and expertise.

8. Contribute to the setup and maintenance of Quality Management Systems (QMS), including process definition and SOP creation.

9. Apply expertise in GAMP5 guidelines and other relevant industry best practices to all validation efforts.

10. Ensure good documentation practices are consistently followed across all quality and validation activities.

Skills and Qualifications:

Mandatory: Proven expertise in Computer System Validation (CSV) - Testing.

Extensive experience in Quality Assurance and Software Testing within the life sciences domain.

In-depth knowledge of GxP, 21 CFR Part 11, ICH GDP, ERES, and GAMP5 guidelines.

Experience with QMS setup, process definition, SOP creation, and SQA activities.





Familiarity with ISO 27001:2013 and ISO IEC 27701:2019 (GDPR) principles.

Strong understanding of IT process implementation and optimization for regulatory compliance.

Ability to manage traceability matrices and support audit management.

Excellent communication, presentation, and interpersonal skills.

Demonstrated ability to work in a client-facing role and manage multiple functions simultaneously.

Highly driven, adaptable, resourceful, and capable of multitasking with a strong attention to detail.

A proactive approach to problem-solving and a commitment to delivering high-quality outputs within timelines.

Skills

Mandatory Skills : Computer System Validation(CSV) - Testing

About LTM
LTM is an AI-centric global technology services company and the Business Creativity partner to the world’s largest and most disruptive enterprises. We bring human insights and intelligent systems together to help clients create greater value at the intersection of technology and domain expertise. Our capabilities span integrated operations, transformation, and business AI — enabling new ways of working, new productivity paradigms, and new roads to value. Together with over 87,000 employees across 40 countries and our global network of partners, LTM — a Larsen & Toubro company — owns business outcomes for our clients, helping them not just outperform the market, but to Outcreate it. Please also note that neither LTM nor any of its authorized recruitment agencies/partners charge any candidate registration fee or any other fees from talent (candidates) towards appearing for an interview or securing employment/internship. Candidates shall be solely responsible for verifying the credentials of any agency/consultant that claims to be working with LTM for recruitment. Please note that anyone who relies on the representations made by fraudulent employment agencies does so at their own risk, and LTM disclaims any liability in case of loss or damage suffered as a consequence of the same. Recruitment Fraud Alert - https://www.ltm.com/careers/recruitment-fraud-alert

📌 Senior Specialist - Quality Engineering (Bengaluru)
🏢 LTM
📍 Bengaluru