SAP Validation Lead
4 weeks ago
About 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 21 CFR Part 11.
- Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system
- Perform GxP and 21 CFR part 11 assessments and develop validation plan
- Develop functional risk strategy and perform functional risk assessment
- Review user business process documents and user requirements specification
- Review functional, technical and configuration design documents
- Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols
- Review the test scripts for the requirements and test scenario coverage
- Lead overall protocol executions, log and track defects
- Review the executed test reports for the proper documentation of test results and evidence
- Review the defects for proper documentation per the checklist
- Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested
- Prepare and approve qualification summary report
- Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
- Maintain overall project and issue tracker and report routinely
- Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release
- Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials
- Maintain day to day activities status tracker and report routinely
- Lead the team of validation engineers located in different time zones
- Excellent communication (oral and written) and attention to detail
- 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
- Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11
- Excellent knowledge of computer system validation and GAMP -5 standards
- Team management
-
SAP Validation Lead
7 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...
-
SAP EWM Lead
1 week ago
California, United States Baer Group The Full timeThe Baer Group is looking for SAP EWM Lead for a 9+ month project located in San Francisco, CA. Title: SAP EWM Lead Location: Remote with Travel to San Francisco, CA Duration: 9 Months Rate: Hourly Plus Expenses Reimbursed Alignment: W2 Only (C2C Not Permitted) Responsibilities: Lead and manage end-to-end SAP EWM implementations, ensuring alignment with...
-
SAP EWM Lead
4 days ago
California, United States Baer Group The Full timeThe Baer Group is looking for SAP EWM Lead for a 9+ month project located in San Francisco, CA.Title: SAP EWM LeadLocation: Remote with Travel toSan Francisco, CADuration: 9 MonthsRate: Hourly Plus Expenses ReimbursedAlignment: W2 Only (C2C Not Permitted)Responsibilities:Lead and manage end-to-end SAP EWM implementations, ensuring alignment with business...
-
SAP FICO Lead Architect
2 weeks ago
California, United States Red Global Full timeRED is currently seeking an SAP FICO LEAD/Architect resource for an initial 6-month contract opportunity with one of our global consulting clients. This project is anticipated to be extended with work being remote primarily on site in San Bernadino, CA. This role is perfect for the local candidate or someone willing to relocate. Suitable Candidates will have...
-
SAP Data Migration lead
6 days ago
Foster City, United States Omni Inclusive Full timeJOB Description: Minimum 12 to 15 yrs of Experience in Master Data Management & Migrations projects. Provide technical guidance/support to the team. Coordinate with onshore SAP Consultants on technical requirements and issue resolutions. Manage Day-to-Day operations and assist Operations Manager in managing the team. Managing communication with Gilead...
-
Sr Validation Lead
11 hours ago
Foster City, United States eTeam Full timeStrong GxP Validation Exp, SAP Implementation Exp, Validation Lead SQA/ VALIDATION/AUTOMATION " Must have 8 years of experience in Selenium Quality Assurance. Primary Responsibilities will include the following :- Experience in software test development and including crating/maintaining test automation- frameworks from scratch. Should have exposure to best...
-
CSV with SAP S4 system validation and Jira Xray
17 hours ago
Jersey City, United States Cygnus Professionals Full timeCSV role. SAP S4 system validation with Jira Xray CSV with SAP S4 system validation and Jira Xray
-
SAP SD Lead
17 hours ago
Jersey City, United States Connexions Data Inc Full timeSAP SD LeadLocation: NJStart: ASAPExp: 14+ Years Need SAP SD lead with S4 Hana implementation. Please send resume toNancy Shaha
-
SAP Bpc Frontend Developer
1 month ago
California City, United States TMS LLC Full time**Company Description** Role: SAP BPC Frontend developer** **Location: Culver City, CA- 100% Remote** **Duration: 12+ Months** **Develop and configure BPC solutions Should have strong development experience in SAP BPC EPM leveraging EPM excel functions and report editor They should also have basic SAP BPC configuration skills such as configuring business...
-
SAP PP Lead
17 hours ago
Jersey City, United States Connexions Data Inc Full timeSAP PP LeadLocation: REMOTEDuration: 6-12 monthsExp: 14+ YearsNeed SAP PP with S4 hana Please send resume toNancy Shaha
-
SAP Basis Lead Consultant
7 days ago
Texas City, United States eTeam Full timeJOB Description: Prior experience working in a Rise with SAP Construct is an added advantage SAP ECC, S4 HANA B4 HANA, BOBJ, BODS, PI experience a must, at least 3-4 full project lifecycles in a Basis team lead / Manager role Worked on ECC 6.0 EhP6, S4 HANA implementation, PI 7.1 and 7.3, BW 7.0 and latest versions of BOBJ, BODS, BWA on at least 1 of...
-
SAP EWM Functional Lead
5 days ago
Jersey City, United States Elite Mente LLC Full timeJob DescriptionJob DescriptionTitle:- SAP EWM Functional LeadLocation:- Remote with Once a month travel to Titusville, NJ Duration:- 12+ MonthsVisa:- USC, GC (W2 Only)Description:Client is looking for SAP TM Consultant.Must have expertise in Functional side. Should be based in ESTPharma Domain Here is a brief role requirement : In this role you will serve as...
-
Senior Validation Project Manager
2 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...
-
Senior Validation Project Manager
1 week ago
Foster City, CA, United States Katalyst Healthcares & 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 the...
-
SAP Afs
4 weeks ago
New York City, New York, United States Vastika Inc Full timeRequirements: Looking for an SAP AFS (OTC/ PTP) Functional Lead - SAP AFS (Apparel and Footwear Solution) experience is a must - Experience in ECC IS- AFS environment, ideally with exposure to both OTC and P2P processes, even if stronger in one area than the other - Ability to navigate through ECC tables and code to confirm data sources for classic BW...
-
SAP BODS Lead
7 days ago
Texas City, United States eTeam Full timeJOB Description: Mandatory Skills: SAP BODS, Project Management Bachelor's degree required; Certification in Project Management preferred. Highly motivated and self-directed Hands-on approach for handling problems and/or issues 10+ years of experience in a project management capacity managing full life cycle SAP initiatives, SAP BODS skill as...
-
SAP TM Functional Lead
5 days ago
Jersey City, United States Elite Mente LLC Full timeJob DescriptionJob DescriptionTitle:- SAP TM Functional LeadLocation:- Remote with travel to NJDuration:- 12+ MonthsVisa:- USC, GC (W2 Only)Should be based in ESTPharma DomainSAP TM Transportation Management Functional Lead.Design business processes, including characteristics and key performance indicators (KPIs), to meet process and functional requirements....
-
Validation Lead
4 weeks 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...
-
SAP SAC Consultant
2 days ago
Culver City, United States Tentek Full timeSAP SAC/BPC Consultant Responsibilities: Develop and maintain SAC data models, data connections, and data transformations. Build custom dashboards, reports, and visualizations. Extensive experience with SAP BW(BW/4) backend and reporting is required Ensure data accuracy and integrity by performing data validation and cleansing. Collaborate with...
-
SAP BTP Portal Lead/ Architect
7 days ago
Texas City, United States eTeam Full timeShould have excellent communication skills, Leadership Skills, and be able to communication with Leadership team Experience with the new SAP BTP platforms and its Portal capabilities 5 years of experience with building Portals sites using the different Portal Services: Experience with SAP Workzone Experience with SAP Launchpad Experience with SAP Portal...