| Validation Engineer with Veeva platform exp. :: TCS - Short Hills, NJ(North) / Roseland Short Hills, NJ at Roseland, New Jersey, USA |
| Email: [email protected] |
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Only H1B and USC! Validation Engineer with Veeva platform exp. Role Description: Meeting with system users to understand the scope of projects Participating in business requirement discussions to draft SDLC /CSV /Qualification documents. Developing validation/qualification/migration/verification strategies for software Executing validation/qualification/verification/migration strategies per quality assurance SOPs.. Providing validation/verification/qualification recommendations to stake holders as necessary. Managing relationships with customers, technical team, quality assurance team, testing team and other stake holders to ensure the validation/ verification/qualification solution delivered to the customer meets expectations. Ensuring SDLC/CSV/Qualification activities are conducted as planned Generate, review, and Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports etc. Working towards project deadlines Communicating findings to technical and non-technical colleagues. Liaising with project teams in other parts of the world Leading the validation effort. Competencies: Digital : DevOps Testing, Life Sciences : Computer System Validation, Veeva Vault Platform Experience (Years): 6-8 Essential Skills: Demonstratable Experience in Computer System Validation (CSV) Experience in software development processes (SDLC) and software testing life cycle (STLC) Experience in drafting, reviewing, revising, and maintaining validation documents (CSV), including Compliance Analysis, Compliance Plan, Change Control Document, User & Functional Requirement documents, Risk Assessments (Risk Register), Test (ST/UAT/Regression) Protocol, Test Defect Report, Test Summary Report, Compliance Summary Report, Traceability Matrix, Hypercare Plan, Operation Run Book and other validation & technical documentation. Experience in drafting Standard Operating Procedures (SOP) and Work Instructions (WI) Strong knowledge of JIRA, HP-ALM, qTest tools Knowledge of validation & testing in projects implemented using agile methodology Knowledge about Agile techniques like: User Stories, Continuous Testing, tasks, etc. Ability to take and understand the commitment to deliver the product on time. GxP experience is required Experience of validation support for 21 CFR Part 11 implementation in Pharma industries. Experience working within a FDA/Other regulated pharma industry. Desirable Skills: Strong verbal and written communication skills with the ability to liaise with a variety of stakeholders Must be self-motivated and pro-active Need to show constant dynamism and able to manage pressure. Attention to detail Competent CSV skills The ability to work in a team and individually Organizational skills with the capability of working towards tight deadlines Able to work with demanding customer Country: United States Branch | City | Location: TCS - Short Hills, NJ(North) Roseland Short Hills, NJ Ashutosh Mishra | Executive Talent Acquisition linkedin.com/in/ashutosh-mishra-allahabadi Teamware Solutions a division of Quantum Leap Consulting Pvt. Ltd 2838 E. Long Lake Road Suite 210, Troy, MI 48085 D : +1 2143909326, ashutosh.m @twsol.com www.teamwaresolutions.net Disclaimer This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to which they are addressed. If you have received this email in error please notify the system manager. This message contains confidential information and is intended only for the individual named. If you are not the named addressee you should not disseminate, distribute or copy this e-mail. Please notify the sender immediately by e-mail if you have received this e-mail by mistake and delete this e-mail from your system. If you are not the intended recipient you are notified that disclosing, copying, distributing or taking any action in reliance on the contents of this information is strictly prohibited. -- Keywords: information technology hewlett packard Michigan New Jersey Wisconsin Validation Engineer with Veeva platform exp. :: TCS - Short Hills, NJ(North) / Roseland Short Hills, NJ [email protected] |
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| 06:50 PM 02-Dec-24 |