10 Nov
|
Bayer
|
Bengaluru
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 diverse and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.IT Quality ExpertPurposeTo 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.ScopeContribute to the IT Management System maintenance and continuous improvementProvide product management support for validation and qualification activitiesEnsure IT supplier quality and compliance aligned with internal standardsSupport audit readiness and remediation activities in IT environmentOperate in an international environment with cross-functional collaborationKey TasksPrepare and maintain validation documentation, including validation plans, risk assessments, requirements traceability, and validation reportsAssess the validation impact of system changes and coordinate updates to affected deliverablesPrepare and review validation test cases and support controlled validation test executionSupport investigations of validation deviations and track related CAPA actionsPerform scheduled periodic reviews of validated systemsCollaborate with cross-functional teams to ensure compliant product developmentMaintain audit readiness and provide evidence for audit scoping and planningProactively identify risks,
evaluate audit and inspection findings, monitor remediation and action plansSupport Quality Assurance Agreements with suppliers.Train teams on compliance and documentation standards.Working RelationsTeam members and Team LeaderSystem Owners, Process Managers, internal clients and cross-functional IT and non-IT teams, external IT Service ProvidersInternal and external auditorsQualificationsSoft SkillsPassion for quality, compliance, and technologyAttention to detail and focus on accuracy and completenessStrong communication and collaboration skillsAbility to work across cultures and global teamsStrong organizational skills and ability to manage multiple tasksWillingness to learn and develop skillsAbility to train and share knowledge with othersHard SkillsUniversity degree in IT, natural sciences, or related fieldApprox 5 years of experience in computerized system validation (CSV) or IT Quality assurance for regulated industriesKnowledge of GxP environment, preferably in the GCP area, and risk-based validation practicesEnglish proficiency at B2/C1 levelAdvanced 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 systemsFamiliarity 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
📌 It Quality Expert (Bengaluru)
🏢 Bayer
📍 Bengaluru