gxp Jobs

As an experienced technical writer at P360, your role will be crucial in enhancing our customer/client-focused services. You will need to have proven expertise in technical fields such as software...
software developmentcomputer scienceengineeringMS Office toolsregulatory requirementsICHproject managementcollaborationcontent developmentinformation architectureSDLCtechnical writerwriting documentationFDAGxP environmentGxP regulationsFDA

As an experienced technical writer at P360, your role will be crucial in enhancing our customer/client-focused services. You will need to have proven expertise in technical fields such as software...
software developmentcomputer scienceengineeringMS Office toolsregulatory requirementsICHproject managementcollaborationcontent developmentinformation architectureSDLCtechnical writerwriting documentationFDAGxP environmentGxP regulationsFDA

Role Overview: As a Service Asset and Configuration Manager (SACM) at PwC, your main responsibility will be to manage an organizations IT assets and configuration items (CIs) throughout their life...
Project ManagementTechnologyProcess OptimizationLeadershipCoachingTeam ManagementContinuous ImprovementQuality ManagementConflict ResolutionTechnical StandardsIT Asset ManagementConfiguration ManagementProfessional StandardsITIL Practices

Job Title: AzureDataEngineer Location:PAN India Experience: 9 Years Work Mode: Hybrid We are seeking a skilled and motivatedDataEngineerto join our team. The ideal candidate will have a stron...
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Role Overview: At Amgen, you will play a crucial role in collaborating with various stakeholders to develop release strategies for Amgens Veeva Vault RIM, ensuring the availability and performance...
information systemsSDLCPythonJavaScriptAgileScrumGitVeeva Vault RIM

As the Scrum Master and Agile delivery leader for Amgens Global Supply Chain Analytics team, you will play a crucial role in facilitating, supporting, and guiding teams to deliver business-critica...
AgileScrumJiraSAFeDevOpsSystem ArchitectureScaled Agile FrameworkData managementBusiness analysisStakeholder managementCommunication skillsLeadershipTeam managementChange managementCollaborationAWS DevOpsCICDCloudbased product environment

As a Computer System Validation (CSV) Engineer, your role involves ensuring that computerized systems used in regulated environments are validated in compliance with regulatory requirements such a...
21 CFR Part 11SDLCMS OfficeGAMP 5

Role Overview: In this vital role, you will be responsible for building, managing, and mentoring an impactful team of data scientists and data engineers operating within agile product teams across...
Data EngineeringChange ManagementData ScientistsData EngineersAgile Product DeliveryData Pipeline DevelopmentManufacturing Data ExpertiseCollaborationCollaborator EngagementGovernanceComplianceTechnology StrategyIncident ManagementRoot Cause Ana

Role Overview: Working at Bristol Myers Squibb offers you a chance to be part of a challenging, meaningful, and life-changing work environment. Each day brings uniquely interesting work in every d...
Quality ManagementRisk ManagementQuality by DesignRegulatory IntelligenceClinical Risk ManagementProcess ImprovementAnalyticsRisk Based MonitoringClinical OversightGxP GCP ComplianceICH Guidelines

As a Lead for Application Managed Services (AMS) and IT Operations Support at Thermo Fisher Scientifics Center of Excellence in India, your role is crucial in connecting technology, people, and pr...
application servicescompliancedata integrityregulatory complianceIT operationsIT supportapplication support servicesincident managementproblem managementchange managementaudit trailapplication supportmaintenanceinfrastructuresecuritystakeho

As a Computer System Validation (CSV) Engineer, your role involves ensuring that computerized systems used in regulated environments are validated in compliance with regulatory requirements such a...
21 CFR Part 11SDLCMS OfficeGAMP 5

Role Overview: Join EY as a Regulatory Compliance Senior in the Enterprise Risk team where you will assist clients by understanding their business needs and delivering solutions in line with EY gu...
CAPAChange ControlComplaints21 CFR Part 11SDLCManufacturingLabsIT project managementChange controlMentoringTrainingTeamworkCollaborationBusiness developmentProcess optimizationOperational efficiencyTechnology alignmentVeeva Vault QM

As a Computer System Validation (CSV) Engineer, your role involves ensuring that computerized systems used in regulated environments are validated in compliance with regulatory requirements such a...
21 CFR Part 11SDLCMS OfficeGAMP 5

As a Computer System Validation (CSV) Engineer, your role involves ensuring that computerized systems used in regulated environments are validated in compliance with regulatory requirements such a...
21 CFR Part 11SDLCMS OfficeGAMP 5

Role Overview: Join EY as a Regulatory Compliance Senior in the Enterprise Risk team where you will assist clients by understanding their business needs and delivering solutions in line with EY gu...
CAPAChange ControlComplaints21 CFR Part 11SDLCManufacturingLabsIT project managementChange controlMentoringTrainingTeamworkCollaborationBusiness developmentProcess optimizationOperational efficiencyTechnology alignmentVeeva Vault QM

Role Overview: As an IS (Information Systems) Audit Senior Associate at Amgen, you will play a vital role in the Corporate Internal Audit group. Your responsibilities will include assisting the Ch...
Information SystemsAuditData AnalysisIntrusion DetectionCOSO FrameworkITILCOBITRegulatory RequirementsClinical TrialsMicrosoft WordExcelCritical ThinkingAnalytical SkillsVerbal CommunicationWritten CommunicationVulnerability AssessmentsPen

As a Werum PAS-X Designer/Developer, you will be responsible for the following key areas: - Having experience in WERUM PAS-X Installation qualifications and version upgradation in the server cli...
MES integrationTroubleshootingAgile Project ManagementGxPGAMP21 CFR Part 11SQL queriesJavaUser managementWERUM PASX Installation qualificationsPASX system administrationSystem life cycle documentationTechnical architecture experienceDatabase

As a Computer System Validation (CSV) Engineer, your role involves ensuring that computerized systems used in regulated environments are validated in compliance with regulatory requirements such a...
21 CFR Part 11SDLCMS OfficeGAMP 5

Role Overview: As an eCompliance Manager at Novartis, you will be responsible for providing Quality Assurance oversight and guidance regarding computerized systems validation (CSV) while operating...
Quality AssuranceGxPRegulatory RequirementsComplianceCloudMobile ApplicationsOperational ManagementITILITSMMESLIMSCRMIAMComputerized Systems Validation21CFR11IT QualitySoftware as a Service SaaSDigital Applications

Role Overview: As a skilled Sr. Associate Validation Analyst at Amgen, your main responsibility will be to oversee and manage validation activities for AI platforms and solutions. You will collabo...
validationcomputer system validationsoftware validationanalytical skillscommunication skillsGXPregulated environmentdevelopingexecuting validation protocolsproblemsolving

As the eCompliance Manager at Novartis Healthcare Private Limited, your primary responsibility is to provide Quality Assurance oversight and guidance regarding computerized systems validation (CSV...
Quality AssuranceGxPRegulatory ComplianceDeviation ManagementProject ManagementQuality ManagementMobile ApplicationsITILITSMPharmaceutical ManufacturingStakeholder ManagementCommunication SkillsNegotiation SkillsInterpersonal SkillsComputeri

As a Computer System Validation (CSV) Engineer, your role involves ensuring that computerized systems used in regulated environments are validated in compliance with regulatory requirements such a...
21 CFR Part 11SDLCMS OfficeGAMP 5

Plant Support Engineer GxP Systems

Location: Duvvada / Pydi Bhimavaram / Hyderab...

gxpuser administrationrestoration

As a SAP Basis Architect at Amgen, you will play a crucial role in supporting the global Enterprise Resource Planning (ERP) landscape, which includes SAP and non-SAP systems hosted on AWS. Your pr...
SAP ECCGTSGRCGISAWSS4HANAATTPATCOnapsisContent ServerSAP BTPSAP HANA database administrationDevOps methodologiesAIML

Role Overview: At Amgen, you will be part of a shared mission to serve patients living with serious illnesses. As a member of the team, you will play a vital role in collaborating with various sta...
information systemsSDLCPythonJavaScriptAgileScrumGitrelational databasesMySQLSQL serverPostgreSQLETL ToolsInformaticaMuleSoftSQL queriesreporting toolsTableauSpotfirePower BIVeeva Vault RIMnetwork technologiesDatabricks

Job Description Role Overview You are an experienced Program Manager cum Release Train Engineer (RTE) joining the team in Chennai, India. Your role involves driving the successful delivery of enha...
PROGRAM MANAGER

Role Overview: As a skilled PLM Software Quality & Validation Engineer at Amgen, your primary responsibility will be to develop, execute, and maintain test scripts for 3DEXPERIENCE PLM platforms a...
Quality AssuranceQA testingValidationTest AutomationComputer System ValidationSoftware ValidationAnalytical skills3DEXPERIENCE platformPLMenterprise software solutionsGxPregulated environment

You will be responsible for configuring and customizing Oracle Argus Safety system, ensuring compliance with regulatory standards and optimizing system performance. Your role will involve designin...
PharmacovigilanceSQLPLSQLSystem IntegrationUser Acceptance testingHealth Care domainOracle Argus SafetyPVSafety systemsRegulatory Standards

As a Vulnerability Assessment and Penetration Testing (VAPT) Team Lead at HackIT, a CERT-IN empaneled cybersecurity firm based in Kochi, you will be responsible for the following: Role Overview: ...
Penetration TestingLeadershipProject ManagementReport WritingCybersecurityWeb Security TestingMobile Security TestingAPI Security TestingNetwork Security TestingStatic Application Security TestingDynamic Application Security TestingProofofConce

ARGUS CONSULTANT (2 to 6 Years) Excellent knowledge of installation/ configuration/ validation of Oracle Argus Safety or other PV/Safety systems. Good knowledge of SQL and PL/SQL. Experience in...
SQLPLSQLOracle Argus SafetyPVSafety systemsRegulatory StandardsFDAMFDSNMPSMexicoTaiwan

Companyis a progressive pharmaceutical certified company by WHO-GMP, MHRA UK, and USFDA, along with approvals from several other countries. It ranks among the top 40 fastest-growing pharmaceutica...
sap consultingsap project managementsap abapsapsap functional consultantssap hana administrationsap hanasap implementationsap ecc

CSV L1 Support (Level 1) The CSV L1 Support Engineer acts as the first line of defense to ensure validated systems remain compliant and operational. This role involves basic troubleshooting, docu...
computer system validationgamp21 cfr part 11

ARGUS CONSULTANT (2 to 6 Years) Excellent knowledge of installation/ configuration/ validation of Oracle Argus Safety or other PV/Safety systems. Good knowledge of SQL and PL/SQL. Experience in...
SQLPLSQLOracle Argus SafetyPVSafety systemsRegulatory StandardsFDAMFDSNMPSMexicoTaiwan

ARGUS CONSULTANT (2 to 6 Years) Excellent knowledge of installation/ configuration/ validation of Oracle Argus Safety or other PV/Safety systems. Good knowledge of SQL and PL/SQL. Experience in...
SQLPLSQLOracle Argus SafetyPVSafety systemsRegulatory StandardsFDAMFDSNMPSMexicoTaiwan

Job title: Pharmacovigilance Audit and Inspection Readiness Expert Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC...
MS OfficeProcess ImprovementStakeholder managementDatabase ManagementPresentation SkillsPV DatabasesPharmacovigilance auditsPV auditsinspections managementICSR quality reviewRegulatory StandardsSafety Reporting RequirementsGood Pharmacovigilanc

About Us dotSolved, headquartered in Silicon Valley USA, is a leading global provider of business process automation, modern application engineering, and cloud infrastructure services. dotSolved ...
communication skillsFDA regulationsGxP guidelinessystem validation methodologieselectronic records managementaudit trailsdata integrity principles

Integration Services: EU Technical Consultant Location: Spain - Barcelona Department: Professional Services Services : R&D Svcs Employmen...