415 Gxp Jobs - Page 6

Role Description: We seek a skilled PLM Software Quality & Validation Engineer to develop, execute and maintain the test scripts for 3DEXPERIENCE PLM platforms and custom-built solutions. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Functional testing and test automation on a cloud-based SaaS PLM software. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and comply with Amgens standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards...

Role & responsibilities Location: Bidar, KA Role: Sr QA Lead JOB DESCRIPTION: 1) Handling of Quality management system. 2) Monitoring Process validation program. 3) Handling of customer and regulatory audits. 4) Monitoring Equipment Qualification program. 5) Coordinate with cross functional team to provide audit response to customer and regulatory agencies. 6) Conducting internal audits as per schedule. 7) CAPA effectiveness verification. 8) Conducting Quality review board meetings and management review meetings as per schedule. 9) Monitoring Equipment cleaning program. 10) Providing necessary documents to address Regulatory Queries, amendments, annual updates and regulatory filings and CMC ...

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrowpeople with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level. About The Role : Job Summary The Healthcare Quality Assurance (QA) System Validation Supervisor provides guidance to UPS Supply Chain So...

JD Description For Junior ICT Administrator Primary Responsibility: To provide support for Bioanalytical systems and users. Actively support participation in System /Software validation activity and its execution. Responsible for IT Server and System Backup and restoration process as defined in Sops, Must have knowledge documenting the activity as per above mentioned. Weekly ,Monthly ,Yearly backup and integrity verification Should have worked as in lead role for team Management. IT Incident management and response management with Quality assurance and Other department stack holder in co-ordination with Vendors. To review IT Sops for any update, amendment and revision if required and send ap...

Configure and manage Continuous Integration and Continuous Deployment (CI/CD) pipelines within a Software as a Service (SaaS) environment Set up the infrastructure for automated code builds, testing, and deployments across various environments such as development, test, staging, and production Work with development teams, Dassault s CI/CD team to understand their needs and ensure that the CI/CD pipelines are aligned with their development practices and releases Strong understanding of Computerized System Validation and demonstrated experience in GxP Documentation Provide technical support to users, troubleshooting and resolving issues related to system access, performance, and software Stron...

Designation: Quality Analyst Preferred Experience: 4+ years We are seeking a detail-oriented and proactive Quality Analyst with a strong background in software testing and experience in the Pharma/Life Sciences domain. The ideal candidate will be responsible for ensuring the quality, accuracy, and compliance of applications through manual and automated testing, while bringing in industry-specific knowledge of pharmaceutical processes, regulatory compliance (GxP, FDA, 21 CFR Part 11), and validation standards. Key Responsibilities: Develop, review, and execute test plans, test cases, and test scripts (manual and automated). Validate software systems to ensure compliance with pharma industry r...

You will be responsible for Veeva QualityDocs Implementation and development with the following key responsibilities: - Must be a Senior Veeva QDoc techno/functional developer with the ability to configure the system - Should have a good understanding of Pharma and legal requirements with broad knowledge - Familiarity with Python is preferred for the role - Should be well-versed in validation, qualification, GxP, and Compliance in a regulated environment - Experience with tools like Jira, qTest, and Vera - Familiarity with SAFe agile methodology No additional details about the company were provided in the job description.,

Dear Candidate, Greetings from Shell Infotech! We are pleased to share an exciting opportunity with one of our esteemed client.Please find the job description and relevant details below for your review. If this opportunity aligns with your interest and profile, kindly respond to this email with your updated CV at premalatha@shellinfotech.com Mode of Hire: Contract to Hire (Initially 6 months-1 Year contract with extension and direct conversion with Client-Deloitte based on your performance) Location: Hyderabad, Bangalore, Chennai, Pune, Mumbai, Gurgaon, Kolkata Mode of work: Hybrid-3days from Office Total Exp:5-14 Years Role/Skill Set: Analyst/Consultant Computerized System Validation Servic...

About the Job The LEDP Release quality coordinator ensures adherence to Sanofi quality standards for each new release of the LEDP platform, including: Proper classification of new release (e.g. minor /major version) and adherence to related release process based on content. Right quality of documentation at each step of the development, testing and release process, as well as application support post release. LEDP is Sanofis backbone to new product development and industrialization. It establishes a data continuity between the CMC and Launch units. It enables paperless tech transfers and serves as a foundation for other digital tools such as Launch Readiness Control tower, One click TT, One ...

Veeva development experience in change Management (Mandatory) Roles and Resposibilities: Veeva development experience in change Management. This role will be responsible for developing and maintaining solution architecture, system administration, security, and procedures across the Veeva Vault Platform. - Support all assigned development activities for the Veeva Vault implementation program under the leadership of the client Quality Veeva team. - Coordinate with Business analysts to outline the business requirements and ensure IT security and Data Integrity requirements are outlined for the solution - Coordinate with Validation team to prepare the Regulatory Applicability Assessment and Regu...

OVERALL OBJECTIVES: As a senior member of the team, you will join a challenging and unique large-scale Transformation Program with high impact and visibility. Primary focus is the assessment, planning and implementation of new or improved IT Services as part of the project engineering team. Senior Reliability Engineer (SRE) is primarily responsible for the engineering, configuration, installation, and maintenance of; Windows physical and virtual servers, Active Directory, Azure cloud and on-prem environments based on Hyper-V/VMWare, storage, backups, and disaster recovery planning. We rely on our engineers to empower our users with high availability, excellent performance levels and key serv...

Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities Design, Build & Optimize End to End SAP Manufacturing Processes for customers enterprise Leading large scale transformation projects Manufacturing Workstream leveraging experience including PP object data migration experience in S/4HANA Conduct systematic client workshops to drive & derive Key Design Decisions with Industry best practice recommendations As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and a...

Responsibilities As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and architecture, and process artifacts, implement the solution and the deployment plan Connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology Contribute to Unit and Organizational initiatives and COEsing potential problems (environments include Sandbox, Development, QA and Production). Additional Responsibilities: SAP BASIS with experience in any of the following industry (Pharma, Professi...

Role & responsibilities : Lead strategic quality initiatives across multiple plants, aligning with business goals and customer expectations. Establish and drive a best-in-class quality culture ensuring compliance with GxP and global regulatory standards. Design and implement robust quality systems and policies to support product excellence and regulatory readiness. Oversee validation and qualification activities for processes and equipment in line with production plans. Ensure timely product transfers and documentation TT Documents, BMR, BPR) for successful site launches. Monitor and respond to regulatory communications ensuring timely submissions and compliance. Institutionalize quality che...

Skill: CSV Manager Notice Period: Immediate . Employment Type: Contract Working Mode : Hybrid Job Description 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

We are looking for a Computer System Validation (CSV) Specialist to ensure that GxP-regulated systems meet compliance requirements in line with 21 CFR Part 11 , EU Annex 11 , and GAMP 5 . The role involves validation of systems used in Quality Control (e.g., LIMS, Chromeleon) and/or Manufacturing operations (e.g., SAP, MES) . The ideal candidate should have hands-on experience preparing and executing validation documents (URS, IQ/OQ/PQ), and strong knowledge of data integrity and GxP practices in the pharmaceutical or life sciences industry.

Role Overview: You will be the Solution Architect - SAP QM at Percipere, responsible for designing, implementing, and supporting business capabilities into SAP QM and related SAP modules. Your role will involve supporting the global supply chain business team in various areas such as Supply Chain, Logistics, Shipping, Inventory Management, and Production Supply. Key Responsibilities: - Establish relationships with Supply Chain and super users globally - Lead engagement efforts from problem definition to solution design, development & deployment - Design, Build & Optimize End to End SAP Quality Management Processes - Collaborate with business users in Supply Chain Dept. and other departments ...

You will be responsible for leading and guiding teams and team captains, assisting in the planning and execution of tasks. Your role will involve fostering a POD culture that values experimentation and ownership while collaborating and coordinating with employees across all levels to prioritize and align POD activities and deliverables. Your aim will be to create a unified team within the POD, ensuring everyone works together towards their objectives. Additionally, you will facilitate meetings for discussions, including brainstorming, problem identification, and solution development, as well as identify and address any risks or issues related to the POD. It will be crucial for you to adhere ...

Role Overview: You will be responsible for administering, configuring, and maintaining EHSQ systems such as Intelex. Your role will involve providing user support, troubleshooting system issues, and coordinating communication between the Quality Team, IT, and software vendors. Additionally, you will work with stakeholders to understand business requirements and translate them into system configurations. Key Responsibilities: - Administer, configure, and maintain EHSQ systems like Intelex. - Provide user support, troubleshoot system issues, and resolve them. - Coordinate and facilitate communication between Quality Team, IT, and software vendors. - Translate business requirements into system ...

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...

Handle pharma systems including LIMS, CSV-validated applications. Ensure compliance with GMP/GxP regulations, 21 CFR part 11 and assist in periodic validation & audits. Provide first-line support for IT systems & infrastructure. Support QA, QC & IT. Required Candidate profile Pharma (USFDA) experience is mandatory. Maintain backup, disaster recovery & cybersecurity protocols, backup. Implement new IT projects & digital transformation initiatives. Document IT incidents.

Looking to onboard a skilled professional with 6-10 years of experience in Documentum to join our team. The ideal candidate will have a strong background in technical applications support, defect fixes, and new feature development. Roles and Responsibility Provide technical applications support for Documentum environments. Work on defect fixes, new feature development, problem tickets, and tasks. Manage release and change request activities. Maintain both production and non-production Documentum environments. Promote standard processes and follow GxP guidelines. Collaborate with cross-functional teams to ensure smooth operations. Job Requirements Minimum 6 years of experience in Documentum. ...

We are looking for a skilled GxP Manual Functional Tester with 5.5-7 years of experience in manual testing in GxP-compliant environments to join our team at IDESLABS PRIVATE LIMITED. Roles and Responsibility Design and execute functional tests for GxP compliance. Collaborate with business, development, and regulatory teams to identify testing requirements. Develop and maintain test cases, scripts, and reports. Track and report defects using tools like Jira. Participate in Agile incremental testing methodologies. Ensure timely delivery of high-quality testing services. Job Requirements Minimum 5.5-7 years of experience in manual testing in GxP-compliant environments. Good understanding of STL...

We are looking for a skilled Validation Engineer with 5 to 8 years of experience. The ideal candidate will have a strong background in validation and CSV experience, as well as knowledge of IQ, OQ, and PQ processes. Roles and Responsibility Design and develop test cases for validation purposes. Collaborate with cross-functional teams to identify and resolve issues. Develop and maintain documentation of validation processes and results. Analyze data to identify trends and areas for improvement. Participate in audits and ensure compliance with regulatory requirements. Provide training and support to junior team members. Job Requirements Bachelor's or Master's degree in Engineering (BE/BTech) o...