CSV Lead
3 weeks ago
- Expertise in conducting Risk Assessment, ensuring compliance to Part 11, 820, GAMP guidelines, Security Assessment, Corrective and Preventive Actions (CAPA) Investigation, GxP (cGMP, GDP, GCP, GLP) suites and Standard Operating Procedures (SOP).
- Expertise in Developing and reviewing SDLC deliverables including Validation Master Plan (VMP), Requirement Specifications (URS/ FRS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Protocols, Requirements Traceability Matrix (RTM), Reports and Validation Summary Reports (VSR).
- Experience in Periodic Review, GAP Analysis, Risk analysis, CAPAs and Remediation Process.
- Experience with end-to-end CSV/Validation process delivery.
- Excellent analytical and documentation skills.
- Customer facing experienceGood communication skills
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Validation Lead
1 month ago
Jersey City, United States RxCloud Full timeJob Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...
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Validation Lead
1 week ago
Jersey City, United States RxCloud Full timeJob Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...
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Validation Lead
11 hours ago
Jersey City, United States RxCloud Full timeJob Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...
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SAP Validation Lead
1 week ago
California City, United States RxCloud Full timeAbout the job SAP Validation Lead Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and...
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SAP Validation Lead
1 month ago
California City, United States RxCloud Full timeAbout the job SAP Validation Lead Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations...
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SAP Validation Lead
3 weeks ago
Texas City, United States eTeam Full timeJOB Description: Roles and Responsibilities 2-4 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements. Working knowledge on end-to-end...
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SAP Validation Lead
2 days ago
Texas City, United States eTeam Full timeJOB Description: Roles and Responsibilities 2-4 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements. Working knowledge on end-to-end...
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AWS Developer
3 weeks ago
Ohio City, United States Saxon Global Full timeJOB DESCRIPTION We are looking for a Lead Software Engineer/Developer for our AWS development team to work in our Digital Payments technology organization who can develop and lead technical delivery of agile development focused on building and supporting new capabilities like modularization, configuration driven enhancement, normalization (to support...
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AWS Developer
2 days ago
Ohio City, United States Saxon Global Full timeJOB DESCRIPTION We are looking for a Lead Software Engineer/Developer for our AWS development team to work in our Digital Payments technology organization who can develop and lead technical delivery of agile development focused on building and supporting new capabilities like modularization, configuration driven enhancement, normalization (to support...
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ESB Tech Lead Engineer
2 weeks ago
New York City, United States Ralph Lauren Full timeCompany DescriptionRalph Lauren Corporation (NYSE:RL) is a global leader in the design, marketing and distribution of premium lifestyle products in five categories: apparel, accessories, home, fragrances, and hospitality. For more than 50 years, Ralph Lauren's reputation and distinctive image have been consistently developed across an expanding number of...
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ESB Tech Lead Engineer
6 hours ago
New York City, United States Ralph Lauren Full timeCompany DescriptionRalph Lauren Corporation (NYSE:RL) is a global leader in the design, marketing and distribution of premium lifestyle products in five categories: apparel, accessories, home, fragrances, and hospitality. For more than 50 years, Ralph Lauren's reputation and distinctive image have been consistently developed across an expanding number of...
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Director of IT
2 weeks ago
Nebraska City, United States Germer International Full timeDirector of IT As the Director of IT, you will be responsible for leading and overseeing the company’s Technology department, including systems and tasks. Responsibilities: Manage and oversee the IT department and coordinate activities with external manager Service Provider (MSP). Maintain computer systems in a regulatory compliant status. Research,...
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Director of IT
9 hours ago
Nebraska City, United States Germer International Full timeDirector of IT As the Director of IT, you will be responsible for leading and overseeing the company’s Technology department, including systems and tasks. Responsibilities: Manage and oversee the IT department and coordinate activities with external manager Service Provider (MSP). Maintain computer systems in a regulatory compliant status. Research,...
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Marketing Administrative Assistant
2 months ago
Salt Lake City, United States Summit Sothebys International Realty Full timeJob DescriptionJob DescriptionSalary: DOESummit Sotheby's International Realty's in-house Marketing Team is growing and is on the hunt for an Administrative Assistant to work with the creative services team. The Marketing Administrative Assistant will work with the lead Marketing Admin, assisting with the proofreading and ordering of all...
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Marketing Administrative Assistant
1 day ago
Salt Lake City, United States Summit Sothebys International Realty Full timeJob DescriptionJob DescriptionSalary: DOESummit Sotheby's International Realty's in-house Marketing Team is growing and is on the hunt for an Administrative Assistant to work with the creative services team. The Marketing Administrative Assistant will work with the lead Marketing Admin, assisting with the proofreading and ordering of all...
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Senior Validation Project Manager
4 weeks ago
Foster City, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. Leads...
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Data Loss Prevention Analyst
1 month ago
Foster City, United States Continuum Resource Network Full timeOur client is an industry leader in on-demand, autonomous ride-hailing. We are leading a search for an experienced Data Loss Prevention Analyst to provide technical support for deploying, configuring, and optimizing the company's DLP security platforms. In this role, you will use DLP tools to: - Better understand the organization's data and information...
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EDI Integration Specialist
1 week ago
Salt Lake City, United States 3PL Central Full timeExtensiv is a visionary technology leader focused on creating the future of omnichannel fulfillment. Through our unrivaled network of more than 2,000 connected 3PLs and a suite of integrated, cloud-native warehouse, order, and inventory management platforms we allow modern merchants and brands to fulfill demand anywhere with superior flexibility and scale...
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EDI Integration Specialist
5 days ago
Salt Lake City, United States Extensiv Full timeExtensiv is a visionary technology leader focused on creating the future of omnichannel fulfillment. Through our unrivaled network of more than 2,000 connected 3PLs and a suite of integrated, cloud-native warehouse, order, and inventory management platforms we allow modern merchants and brands to fulfill demand anywhere with superior flexibility and scale...
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Technical Account Manager
2 weeks ago
Jersey City, United States Dtcc Full timeJob Description Are you ready to make an impact at DTCC? Do you want to work on innovative projects, collaborate with a dynamic and supportive team, and receive investment in your professional development? At DTCC, we are at the forefront of innovation in the financial markets. We're committed to helping our employees grow and succeed. We believe that you...