IT Quality Expert

Biopharma Asia; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Bayer is hiring an IT Quality Expert in Bengaluru to ensure quality and regulatory compliance of computerized systems, IT operations, and suppliers. The role covers validation, qualification, change control, deviation management, and audit readiness in an international context.

We seek about five years of CSV/IT quality experience, with GxP knowledge and strong English skills. The candidate will train teams in compliance and support audits and supplier QA agreements.

Qualifications

• University degree in IT, natural sciences, or related field.
• Approx 5 years of experience in computerized system validation (CSV) or IT Quality assurance for regulated industries.
• Knowledge of GxP environment, preferably in the GCP area, and risk-based validation practices.
• English proficiency at B2/C1 level.
• Advanced Microsoft Office skills (Excel, Word, PowerPoint).
• Experience with software development, agile environment and digital collaboration tools (Teams, SharePoint, Jira, AzureDevOps).
• Basic knowledge of document management and validation lifecycle systems.
• Familiarity with audit, risk, change, or deviation management (beneficial).
• Exposure to Veeva Vault products, Clinical Data management systems, or cloud-based integration and data platforms is an advantage.

Responsibilities

• Prepare and maintain validation documentation, including validation plans, risk assessments, requirements traceability, and validation reports.
• Assess the validation impact of system changes and coordinate updates to affected deliverables.
• Prepare and review validation test cases and support controlled validation test execution.
• Support investigations of validation deviations and track related CAPA actions.
• Perform scheduled periodic reviews of validated systems.
• Collaborate with cross-functional teams to ensure compliant product development.
• Maintain audit readiness and provide evidence for audit scoping and planning.
• Proactively identify risks, evaluate audit and inspection findings, monitor remediation and action plans.
• Support Quality Assurance Agreements with suppliers.
• Train teams on compliance and documentation standards.

Skills

Attention to detail

Communication skills

Team collaboration

Cross-cultural collaboration

Organizational skills

Education

University degree in IT / natural sciences

Tools

Jira

SharePoint

Teams

AzureDevOps

Veeva Vault

Job description

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

IT Quality Expert

Purpose

To ensure the quality and regulatory compliance of the computerized system, related IT operations and IT suppliers. The role supports validation and qualification activities throughout system maintenance and development, including change control, deviation management, periodic reviews, while maintaining audit readiness.

Scope

Contribute to the IT Management System maintenance and continuous improvement

Provide product management support for validation and qualification activities

Ensure IT supplier quality and compliance aligned with internal standards

Support audit readiness and remediation activities in IT environment

Operate in an international environment with cross-functional collaboration

Key Tasks

Prepare and maintain validation documentation, including validation plans, risk assessments, requirements traceability, and validation reports

Assess the validation impact of system changes and coordinate updates to affected deliverables

Prepare and review validation test cases and support controlled validation test execution

Support investigations of validation deviations and track related CAPA actions

Perform scheduled periodic reviews of validated systems

Collaborate with cross-functional teams to ensure compliant product development

Maintain audit readiness and provide evidence for audit scoping and planning

Proactively identify risks, evaluate audit and inspection findings, monitor remediation and action plans

Support Quality Assurance Agreements with suppliers.

Train teams on compliance and documentation standards.

Working Relations

Team members and Team Leader

System Owners, Process Managers, internal clients and cross-functional IT and non-IT teams, external IT Service Providers

Internal and external auditors

Qualifications

Soft Skills

Passion for quality, compliance, and technology

Attention to detail and focus on accuracy and completeness

Strong communication and collaboration skills

Ability to work across cultures and global teams

Strong organizational skills and ability to manage multiple tasks

Willingness to learn and develop skills

Ability to train and share knowledge with others

Hard Skills

University degree in IT, natural sciences, or related field

Approx 5 years of experience in computerized system validation (CSV) or IT Quality assurance for regulated industries

Knowledge of GxP environment, preferably in the GCP area, and risk-based validation practices

English proficiency at B2/C1 level

Advanced Microsoft Office skills (Excel, Word, PowerPoint)

Experience with software development, agile environment and digital collaboration tools (Teams, SharePoint, Jira, AzureDevOps)

Basic knowledge of document management and validation lifecycle systems

Familiarity with audit, risk, change, or deviation management (beneficial)

Exposure to Veeva Vault products, Clinical Data management systems, or cloud-based integration and data platforms is an advantage

YOUR APPLICATION

Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.

Location:

India : Karnataka : Bangalore || Poland : Pomorskie : Gdańsk

Division:

Enabling Functions

Reference Code:

896276

Contact Us

+ 022-25311234