CSV Test Plans Specialist (Jobs in Waltham, MA)   Requirement id 88322 Job title Specialist Job location in Waltham, MA Skills required 21 CFR Part 11 Gap Analysis, CSV, Desing Documentation, Test Plans Open Date 07-Feb-2019 Close Date Job type Contract to Hire Duration 6 Months Compensation DOE Status requirement --- Job interview type ---    Email Recruiter: coolsoft Job Description Specialist: 21 CFR Part 11 Gap Analysis, CSV, Desing Documentation, Test Plans job Description : Summary The Validation Project Lead is responsible for developing and implementing compliance documents identified in previous phase of SAP Remediation project. The responsibilities for this position include ensuring all quality documents and tasks performed to remediate the existing SAP system as per regulatory & compliance standards. This role will interface with IT and Business Process teams. Responsibilities: Review validation deliverables Maintain close communication with stakeholders and team members to update status, follow up and to work closely to complete scheduled tasks. Assist in planning, conducting, and documenting user acceptance testing Review and validate Functional and Technical Specifications of SAP transactions Review computerized systems validation documents such as: Requirements Specification Design Specification CSV Validation Plan & Summary Test Plans Pre/Post Executed test Scripts Traceability Matrix Education & Experience: 4+ years experience with Life Science industries Project Management experience (PMP is a plus) Prior experience with documentation for GxP, 21CFR Part-11, FDA and/or other applicable global health authority regulations. Possess expertise on Good Documentation and Good Testing practices. Working knowledge of SAP ERP application (minimum 5 years as a consultant) Experience in facilitating the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of computer application Advanced knowledge of complete MS Office suite and MS Project. Excellent oral and written communication skills in English. Job Type: Contract Education: Bachelors (Preferred)   Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 88322 while calling.   Other jobs in MA: Boston (103), Burlington (1), Cambridge (1), Canton (3), Chelsea (9), Franklin (1), Lexington (2), Malden (10), Marlborough (2), Maynard (2), Newton (1), Quincy (6), Sharon (1), Waltham (1), Welesley (1), Wellesley (6), Westborough (1), Westbourough (1),    21 CFR Part 11 Gap Analysis job openings in other states Jobs List IT Business Analyst Regulatory Analytics - J-11-413-778 Create date: 03-Jun-2019 start date:6/24/2019 End date:12/23/2019 submission deadline:6/19/2019 Description: IT Business Analyst Regulatory Analytics - 32954251 Job Owner: .... (This job is for - job Jobs in CA Alameda Analyst - (in Alameda, CA)) IT - Validation Tester - J-10-661-271 Create date: 11-May-2012 [**Note : Dead Line : 05/16/2012**] [Note : Start Date : 06-04-2012 End Date : 08-31-2012] Description : The Software Validation Associate position is a key member of the Business and Facility Systems Validation team within the Technical Services organization. The Software Validation Associate must h.... (This job is for - job Jobs in IN BLMGTN Tester - (in BLMGTN, IN))     (Specialist: 21 CFR Part 11 Gap Analysis, CSV, Desing Documentation, Test Plans in Waltham, MA)

Featured Jobs Troubleshooting Engineer (Jobs in Des Moines, Iowa) Application Developer (Jobs in Richmond, Virginia) Business Analyst Business Analyst (Jobs in Richmond, Virginia) Consultant (Jobs in Murfreesboro, Tennessee) TFS Automation Analyst (Jobs in Dimondale, Michigan) Cloud Architect (Jobs in Lansing, Michigan) GitHub Consultant (Jobs in Lansing, Michigan) IT Developer (Jobs in Atlanta, Georgia) Microsoft Consultant (Jobs in ANDERSON, South Carolina) Business Analyst JAD SQL Analyst (Jobs in Lansing, Michigan)