Sr Analyst

Merck; Bengaluru; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Merck is seeking an IT Qualification Support professional to prepare and manage qualification documents across the IT lifecycle. The role collaborates with Qualification Owners and Process Owners to ensure all regulatory and technical requirements are met.

The candidate should have a minimum of 5 years in IT Systems/Infrastructure or Computer System Validation, with strong knowledge of GAMP5 and IT infrastructure technologies. Familiarity with enterprise applications is a plus.

Qualifications

• Bachelor's degree in technical discipline or equivalent with relevant work experience.
• Minimum 5 years in IT Systems/Infrastructure or Computer System Validation.

Responsibilities

• Prepares and manages qualification documents using approved templates and ensures review workflow.
• Liaises with Compliance and Qualification Owners to meet requirements and drive quality improvements.
• Monitors qualification status, tracks updates, and notifies owners as appropriate; supports new projects and non-conformances.
• Covers technical IT infrastructure domains including networks, servers, storage, AD, virtualization, cloud, and databases.
• Experience with Enterprise and Business Applications is advantageous.

Skills

Documentation

GxP knowledge

IT infrastructure

Regulatory understanding

Education

Bachelor's degree in IT/Engineering

Tools

GAMP5

Job description

• The IT Qualification Support role is responsible to prepare the Qualification Documents, in collaboration with the respective Qualification Owners, Process Owners and other necessary stakeholders.
• Provides support for all Qualification Documents that are required to be established and maintained throughout the Qualification lifecycle of IT Systems/ Infrastructure.
• Drives partnership and acts as key link between Process Owners for Qualification the Qualification Owners.

Core Responsibilities.

• Prepares and manages qualification documents (eg, Qualification Plan, Risk Assessment, Technical Specifications, Installation Qualification Protocol, Functional Infrastructure Test, Qualification Report, Periodic Review, Decommission etc) using approved templates, ensures stakeholder review and approval workflow.
• Liaises with Compliance and Qualification Owners to ensure qualification requirements are met and drives process improvements data quality.
• Monitors qualification status, tracks due updates, identifies discrepancies, and notifies Qualification Owners or Process Owners as appropriate. Supports qualification requirements for new projects, actions related to non-conformances, continual improvement, supplier assessments, compliance reporting and automation initiatives related to Qualification.
• Technical Regulatory Requirement.
• Understanding of Computer System Validation. Understanding of GAMP5 - A Risk based approach to Compliant GxP Computerised systems.
• Technical knowledge on IT Infrastructure technologies like Network, Servers(Windows, Linux etc), Storage Backup(Netapp, TSM, Commvault etc), Active Directory, Virtualization (ESX, vCenter, Citrix etc) , Cloud Platforms(AWS, Azure etc), Database etc
• Experience working on Enterprise Applications and Business Applications would be an advantage.

Education experience

Bachelors degree in Technical discipline or any other degree with relevant work experience.

Minimum 5 years experience in service based roles in IT Systems/ Infrastructure or Computer System Validation.

Role Level - Expert 2, MGCC.