Quality Engineer

Ecolab Global Services; Pune District; Híbrido; INR 1.000.000 - 1.800.000; Jornada completa

Descripción de la vacante

Ecolab Global Services seeks a Quality Engineer-CSV to drive computer system validation and compliance across global projects. You will assess GxP applicability, apply 21 CFR Part 11 and EU Annex 11, and perform risk-based validation using FMEA.

The role emphasizes AI validation, data integrity, and adherence to GAMP5 guidelines. You will collaborate with management, CSV teams, and stakeholders to ensure timely delivery, develop validation documentation, and support lifecycle maintenance of

Formación

• Bachelor's degree or higher in engineering or a scientific discipline (Pharmacy/Biologics, CSE or Instrumentation preferred).
• 3–7 years of experience in computer system validation, instrument validation, and quality systems.
• Understanding of QMS processes, incident management, CAPA, and deviation management.
• Familiarity with Azure DevOps for backlog, user stories, sprint activities, defect tracking, traceability, and reporting.
• Certification in Microsoft Copilot or AI tools is preferred.
• Knowledge of ISO 9001:2026 requirements (mandatory).
• Knowledge of ISO 13485:2016 (good to have).

Responsabilidades

• Collaborate with management, global CSV teams and stakeholders to understand requirements and deliver validation tasks on time.
• Perform GxP assessments to determine system applicability and validation requirements.
• Apply 21 CFR Part 11, EU Annex 11, and data integrity guidance throughout validation activities.
• Apply GAMP 5 guidelines in planning and executing validation activities.
• Perform risk-based validation and FMEA-based risk assessments.
• Prepare and review validation plans, risk assessments, test protocols and traceability matrices.
• Execute validation activities in line with SDLC methodology.
• Support risk-based AI validation for GxP use including data quality and monitoring.
• Validate GAMP Category 4 and 5 software as applicable.
• Perform eQMS enhancements and workflow validation to ensure intended functionality.
• Use HP ALM to manage validation requirements, test execution, defects, and traceability.
• Conduct IT quality reviews of change controls and incident records.
• Periodic reviews of validated systems and Kaizen initiatives for process improvements.
• Decommissioning and retirement of legacy systems.

Conocimientos

GxP validation

QMS processes

Regulatory compliance

Azure DevOps

AI validation

Audits readiness

Documentation

Educación

Bachelor's degree in engineering/science

Herramientas

Azure DevOps (ADO)

HP ALM

Copilot / AI tools

Descripción del empleo

Quality Engineer- CSV:

DUTIES & RESPONSIBILITIES:

• Collaborate with management, global CSV teams, and business stakeholders to understand requirements, communicate project status, and deliver assigned validation responsibilities within agreed timelines.
• Perform GxP assessments to determine system applicability and associated validation requirements.
• Apply 21 CFR Part 11 and EU Annex 11 requirements, MHRA Data Integrity Guidance, and ALCOA+ principles throughout computer system validation activities.
• Apply GAMP 5 guidelines when planning and executing computer system validation activities.
• Perform risk-based validation and complete system risk assessments using Failure Mode and Effects Analysis (FMEA).
• Prepare, review, and approve validation documentation, including validation plans, risk assessments, test protocols, traceability matrices, validation reports, and associated deliverables.
• Execute computer system validation activities in accordance with the Software Development Life Cycle (SDLC) methodology.
• Support risk-based AI validation for intended GxP use, covering data quality, model performance, reliable outputs, human oversight, ongoing monitoring, and change control.
• Perform validation of GAMP Category 4 and Category 5 software, as applicable to assigned projects.
• Perform eQMS enhancements and workflow validation to ensure intended functionality, data integrity, and compliance with approved requirements.
• Ability to use AI-enabled tools, Microsoft Copilot to streamline validation activities
• Use HP ALM to manage validation requirements, test execution, defects, and traceability.
• Perform IT Quality reviews of change controls and incident management records as part of ongoing validated system maintenance.
• Conduct periodic reviews of all validated systems to assess their continued validated state.
• Participate in Kaizen initiatives to drive continuous improvement in validation processes, efficiency, and quality.
• Execute decommissioning and retirement activities for legacy computer systems.

QUALIFICATIONS

A bachelors degree or higher in engineering or a scientific discipline, preferably Pharmacy/Biologics, Computer Science and Engineering, or Instrumentation.

• 3–7 years of relevant experience in computer system validation, instrument validation, and quality systems.
• Understanding of Quality Management System (QMS) processes, including incident management, corrective and preventive action (CAPA), and deviation management.
• Understanding of quality principles, regulatory compliance, and audit readiness requirements within the pharmaceutical and healthcare sectors.
• Familiarity with Azure DevOps (ADO) for backlog management, user stories, sprint activities, defect tracking, requirements traceability, and project reporting.
• Certification in Microsoft Copilot or other AI-enabled productivity tools is preferred.
• Knowledge of ISO 9001:2026 Quality Management System requirements (mandatory)
• Knowledge of ISO 13485:2016 MD Quality management systems — Requirements for regulatory purposes (good to have)

Other skills required:

• Excellent written and oral communication
• Team player who is easy to work with
• Combination of big picture understanding and vision with outstanding attention to detail
• Problem solver with strong analytical skills – comfortable with both theoretical and practical issues
• Able to work independently and within a team.
• Strong ability to document work.
• Able to prioritize tasks effectively and to communicate roadblocks promptly to management within a fast-paced environment where project / team priorities may shift.