| Validation Lead Veeva _ Short Hills, NJ(North) at North, Virginia, USA |
| Email: [email protected] |
| Greetings, We have the below requirement with our client. Kindly go through the JD below and let me know your interest Role name: Lead Short Hills, NJ(North) Duration : Contract 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 Best Regards, Jessica(Bhargavi Jalthar) |Sr Technical Recruiter| Email: [email protected] Siri InfoSolutions Inc , 3 Ethel Rd, Suite # 302, Edison NJ 08817. Disclaimer: We respect your online privacy. If you would like to be removed from our mailing list please reply with "Remove" in the subject and we will comply immediately. We apologize for any inconvenience caused. Please let us know if you have more than one domain. The material in this e-mail is intended only for the use of the individual to whom it is addressed and may contain information that is confidential, privileged, and exempt from disclosure under applicable law. If you are not the intended recipient, be advised that the unauthorized use, disclosure, copying, distribution, or the taking of any action in reliance on this information is strictly prohibited. We are an equal opportunity employer with a diverse workforce. Note : Any resume submitted by Siriinfo is presented with the understanding that the candidate is being considered for your direct end-client (end-client is the company where the work will be performed). If there is any other company involved between the end-client and your company, please do not submit this resume without our written approval. If you submit the resume to another third party, Siriinfo reserves the right to work with the third party directly. -- Keywords: information technology golang hewlett packard New Jersey Wisconsin Validation Lead Veeva _ Short Hills, NJ(North) [email protected] |
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| Thu Dec 05 04:21:00 UTC 2024 |