Specialist - Quality Engineering

LTM; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

LTM is seeking a Validation Engineer in Bengaluru with extensive experience in Computer System Validation and Quality Assurance for Life Sciences applications. You will drive compliance-led validation activities, support audits, and coordinate with cross-functional teams to ensure regulatory readiness across processes.

The role requires hands-on experience with GAMP5, 21 CFR Part 11, and GxP standards, along with strong documentation practices and stakeholder communication skills.

Qualifications

• Experience in Computer System Validation and Quality Assurance.
• Proficient in regulatory standards and GAMP5 guidelines.
• Knowledge of 21 CFR Part 11 and GDPR compliance.
• Sound experience in QMS setup and document control.

Responsibilities

• Own end-to-end validation processes for life sciences applications.
• Collaborate with project management to drive application development and maintenance.
• Support audit management and internal/external inspections.
• Maintain traceability matrices and ensure GXP compliance.

Skills

Validation

Quality Assurance

Tools

GAMP5

21 CFR Part 11

GxP Compliance

ISO IEC GDPR

Job description

Job Summary

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 Internal Auditor Training ICH GDP ERES GAMP and GAMP5 Certified in ISO IEC 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: Good 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

Nice to have

• Good 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