Role description
Role :Validation Engineer
Experience in Computer System Validation and Quality Assurance Software Testing activities for Life Sciences Applications IT Process implementation
Optimization from compliance to regulations standards to regulatory in spections waterfall to agile perspectives from Pharmaceutical Company
Proficient ISO 270012013
Internal Auditor Training ICH GDP ERES GAMP and GAMP5 Certified in ISO IEC 277012019 GDPR Lead Implementer
Training Experience in QMS set up Proce ss Definition SOP Creation SQA activities Validation activities GXP Compliance and Good Documentation
Practice Sound Knowledge in 21 CFR Part 11 and GXP and GAMP Ownership of End to End Validation
Process Collaboration with Project Management I ntegration Management to drive Application Development and Maintenance
Projects Involved in Trace ability Matrix Management Creation of VP VR IQ Baseline Reports in AD Projects with ISPDM process
Provided End to End support in tracking revie w ing and approving all the quality deliverables in projects Involved in Supporting Audit Management Related Activities Internal External
Nice to have:
Valuable communication and presentation skills
Worked in business client facing role
Highly driven energetic flexible resourceful ability to multitask
Clarity of thought and vision
Ability to ideate and bring solutions to the table
Adherence to timelines without sacrificing quality of output
Hands on and detail oriented with a strong ability tocoo rdinate across different Geographies and with different stakeholders
Ability to manage multiple functions at same point of time
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
📌 Specialist - Quality Engineering (Bengaluru)
🏢 LTM
📍 Bengaluru