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Validation Analyst (SAP)
| Details |
Country: USA
Location: MA Framingham/Worcester
Total applied: 5
Relevant Work Experience: 2+ to 5 Years
Career Level: Experienced (Non-Manager)
Education Level: Bachelor's Degree
Job Type: Employee
Job Status: Full Time
Job Shift: First Shift (Day)
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Validation Analyst (SAP)
Validation Analyst
Support operations through the client's system's support structure. Specific areas of responsibility are in the area of SAP validation within the areas of: Operations, Finance, Supply Change, Sales & Marketing and Quality Assurance. The overall objective is to provide global solutions to meet the business and regulatory requirements of the client.
Duties and Responsibilities:
Work with the business units to apply the QMAC policy for SAP software systemAssist users in understanding the fundamentals of software validationConduct validation per QMAC on new or legacy systemsOversee the Quality plan and other validation documentationDefine the software validation activities to be conducted by the projectComplete assigned tasks within the scope of the work plan and under the supervision of the Validation ManagerLearn necessary analytical tools, engagement tools, and technologies/systems needed to complete workMaintain awareness of business needs, expectations, and level of satisfaction; communicates areas of concern to validation/project manager
Common Responsibilities:
Produce quality project deliverables (including Validation Plans, IQ/OQ/PQ reports, testing reports and summary reports) in support of client's projectsDevelop knowledge of methodology, application areas, writing, and presentation skillsAdhere to the confidentiality, protection of proprietary information, and other legal responsibilities
Minimum Education & Experience:
2 ? 3 years experience with GCP, GLP, GMP, 21 CFR Part 11 & 21 CFR Part 820
Familiarity with SDLC and software applications, including SAP, PDM a plus
Effective use of MS Office products
Ability to work independently and on a team
Hands on experience in computer systems is preferred
Bachelor?s degree
Good communication and interpersonal skills.
Specific process knowledge and related experience
Knowledge of related business applications preferred
Self starter with strong, proactive work ethic
Project Management skills a plus
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