- 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
20 hours ago
RxCloud California City, United StatesAbout 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 monit ...
-
Program Manager
6 days ago
Stratolaunch Mojave, United StatesStratolaunch is a technology accelerator that engineers operationally realistic testing at Mach 5+. Our air-launched, Talon testbeds are reusable, cost-effective platforms that enable routine access to the hypersonic environment. We deliver flight data critical to validating syst ...
-
Procurement Agent
3 weeks ago
Stratolaunch Mojave, United StatesStratolaunch is a technology accelerator that engineers operationally realistic testing at Mach 5+. Our air-launched, Talon testbeds are reusable, cost-effective platforms that enable routine access to the hypersonic environment. We deliver flight data critical to validating syst ...
-
Manager, Administrative Services
2 weeks ago
Stratolaunch Mojave, United StatesStratolaunch is a technology accelerator that engineers operationally realistic testing at Mach 5+. Our air-launched, Talon testbeds are reusable, cost-effective platforms that enable routine access to the hypersonic environment. We deliver flight data critical to validating syst ...
-
Recreation Assistant
2 weeks ago
US Air Force Materiel Command Edwards AFB, United States**Duties**: · - Executes equipment checkout transactions using the RecTrac computer system. · - Ensures equipment is clean and serviceable at time of check in. · - Performs regular equipment inventories to maintain cleanliness and serviceability. · - Accepts payments and executes ...
-
Deployable Manager Product Support 1
1 week ago
Northrop Grumman Edwards AFB, United States**Requisition ID: R **: · - ** Category**: Technical Support · - **Location**: Edwards AFB, California, United States of America · - **Clearance Type**: Secret · - **Telecommute**: No · - Teleworking not available for this position · - **Shift**: Any (United States of America) · ...
-
Deployable Logistics Support 3
1 week ago
Northrop Grumman Edwards AFB, United States**Requisition ID: R **: · - ** Category**: Manufacturing and Production · - **Location**: Edwards AFB, California, United States of America · - **Clearance Type**: Secret · - **Telecommute**: No · - Teleworking not available for this position · - **Shift**: Any (United States of ...
-
Electronics Technician Ii or Iii
6 days ago
Arcata Associates, Inc. Rosamond, United States**Electronics Technician II & III** · The Electronics Technician position is accountable to the Work Group Lead (WGL) and the Mission Support Services (MSS) Manager for the overall support of in-scope work in The RF communications Department (WBS-160). This includes supporting an ...
-
Senior Project Manager
3 weeks ago
ADDSOURCE California City, CA, United StatesExperience: This classification requires a minimum of 15 years of broad, extensive, and increasingly responsible experience applying PM principles, methods, techniques, and tools. At least four 10 years of that · experience must have been as a senior PM of one or more large or co ...
-
Senior Project Manager
2 weeks ago
VeeRteq Solutions Inc. California City, United StatesJob Description · Job Description · Experience: · This classification requires a minimum of 15 years of broad, extensive, and increasingly responsible experience applying PM principles, methods, techniques, and tools. At least four 10 years of that · experience must have been ...
-
account manager/project manager
2 weeks ago
gpac California City, United StatesA top commercial flooring company is currently looking for a highly skilled Account Manager/Project Manager to join their growing team. You will work with clients to specify products and installation services for specific projects. This person will also present products/services ...
-
Principal Engineer Supplier Quality
2 days ago
Northrop Grumman California City, United StatesRequisition ID: R · Category: Engineering · Location: Woodland Hills, California, United States of America | Redondo Beach, California, United States of America · Clearance Type: Secret · Telecommute: Yes- May Consider Full Time Teleworking for this position · Shift: 1st Shift ...
-
Sales Manager-West
3 weeks ago
Vitasoy North America Inc. California City, United StatesJob DescriptionJob Description · Background · Vitasoy International is a leading manufacturer and distributor of plant-based beverages and food listed on the Hong Kong Stock Exchange (HK0345). Established in 1940 by Dr Kwee-seong Lo, we promote sustainable nutrition through our h ...
-
Part Time Nabisco Merchandiser/Order Writer
2 weeks ago
Mondelez International California City, United States Part timeJob Description · Join our Mission to Lead the Future of Snacking AT Mondelēz International · Part Time Nabisco Merchandiser/Order Writer · Join our team of Part Time Nabisco Merchandiser and fulfill the merchandising needs of our customers through communication & relationship bu ...
-
Business Account Executive CA
2 weeks ago
Spectrum California City, United StatesAverage target compensation $100k plus, with minimum commission guarantee · JOB SUMMARY · The Business Account Executive is responsible for selling primary and ancillary communications solutions to small and medium sized businesses within a specified territory. Primary services ...
-
Part Time Nabisco Merchandiser/Order Writer
2 weeks ago
Mondelez International California City, United States Part timeJob Description · Join our Mission to Lead the Future of Snacking AT Mondelēz International · Part Time Nabisco Merchandiser/Order Writer · Join our team of Part Time Nabisco Merchandiser and fulfill the merchandising needs of our customers through communication & relationship bu ...
-
MBSE / Principal MBSE Systems Engineer
3 days ago
Northrop Grumman California City, United StatesRequisition ID: R · Category: Engineering · Location: Woodland Hills, California, United States of America · Clearance Type: Secret · Telecommute: No- Teleworking not available for this position · Shift: 1st Shift (United States of America) · Travel Required: Yes, 10% of the Ti ...
-
VP-Strategic Account
1 week ago
Alight California City, United StatesVP, Strategic Accounts · Are you a Strategic Account expert looking for a new opportunity? · Are you excited by the prospect of working with prestigious global brands? · Our Story · At Alight, we believe a company's success starts with its people. At our core, we Champion Peo ...
-
Packaging Operator
16 hours ago
Shell California City, United StatesWhat's the Role? · The successful candidate will be responsible for the support of packaging and warehouse operations including running packaging equipment, driving forklifts, managing warehouse inventory, loading and unloading trucks. · The successful candidate will be involved ...
-
Deployable Manager Product Support 1
4 days ago
Northrop Grumman Edwards AFB, United States**Requisition ID**:R **: · - ** Category**: Technical Support · - ** Location**: Edwards AFB, California, United States of America · - ** Clearance Type**: Secret · - ** Telecommute**: No · - Teleworking not available for this position · - ** Shift**: Any (United States of Americ ...
SAP Validation Lead - California City, United States - RxCloud
Description
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.
