| Urgent Requirement for Veeva Vault Consultant with pharma domain - San Francisco, CA- Hybrid Locals at Francisco, Indiana, USA |
| Email: [email protected] |
| From: Narsimha Kathi, iTech US [email protected] Reply to: [email protected] Hi , We have a job opportunity for you, please find the below details and let me know your interest ASAP. Role: Veeva Vault Consultant with pharma domain Location: San Francisco, CA Duration: Long Term Contract Responsibilities: Veeva Vault Consultant with pharma domain Provide consulting, author proposals, design, build, Configure and support Veeva QMS, Veeva Vault based applications to meet business process and application requirements. Provide training and support to employees on Veeva QMS, as well as on QMS procedures and best practices, in general. Knowledge on handling events QARs, CAPAs, Change controls, qualification document review and compliance. Stay updated on industry trends and regulatory changes to ensure continuous compliance. Lead the development and execution of QMS processes, including document control, change management, and CAPA (Corrective and Preventive Actions). Collaborate with cross-functional teams to assess and enhance quality processes throughout the product lifecycle. Drive continuous improvement initiatives to optimize QMS efficiency and effectiveness. Prepare and present reports on quality metrics and compliance status to management. Support the on-going regulatory compliance of the IT components for defined services to ensure the proper integration and functionality of the Veeva QMS system. Strong project management skills with a focus on delivering results within deadlines. Review and approve regulatory system changes and documentation. Solves a range of straightforward problems through knowledge and technical experience in own discipline with a moderate level of guidance. Support periodic reviews of the entire system and compile related reports during operation phase. Understands how the team integrates with other teams to achieve overall objectives of the area and builds knowledge of the organization, processes, customers, and key business drivers. Essential Skills: IT Manufacturing Domain (Qualification implementation and Advisory in Veeva QMS) Minimum 6 years of IT experience in pharma domain for implementing and managing Veeva QMS. Minimum of Bachelors Degree or applicable experience within information/Computer systems with focus on Qualification of Mfg. applications Must have experience on implementation, consulting for Veeva QMS in Life Sciences. Deep knowledge of Veeva QMS, Veeva Vault configuration, developing them in live projects based on client requirement. Previous experience in the biotechnology / Pharmaceutical / Life Science or related industry implementing and validating computer systems that manage regulated information. Working knowledge of IT infrastructure qualification processes and IT operating procedures Thoroughly familiar with Quality GxP IT compliance requirements. Strong planning and analytical skills combined with ability to work with geographically distributed teams in a rapid development model. Awareness of ITIL and Support Project Methodology. Ability to familiarize himself / herself independently with entirely new subjects and thus provide comprehensive and innovative solutions. Excellent written and verbal communications skills Solid grasp of Information security and standard methodologies Working knowledge of Document and Object record migration from legacy application to Veeva Vault. Good technical knowledge in core technologies and platforms such as Java, .Net, XML, HTML, PL/SQL API. In-depth knowledge of quality management principles and industry regulations (e.g., FDA, ISO). Qualified on Global Quality tracking systems for initiation handling and closure of investigation. Desirable Skills: Good communication skills Manufacturing domain experience/ ISA 95 Certifications in relevant quality management systems and regulatory affairs are a plus. Any certfication related on Veeva vault QMS. SUBMISSION DETAILS LinkedIn: Consultant Name: Current Location: Relocation (Yes/No): Highest Qualification: Year/College/University: Passport number: Thanks & Regards Narsimha Kathi iTechUS, Inc Direct: 802-735-0270 Phone: 802-383-1500 Ext 141 Keywords: information technology procedural language California Urgent Requirement for Veeva Vault Consultant with pharma domain - San Francisco, CA- Hybrid Locals [email protected] |
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| Mon May 20 21:01:00 UTC 2024 |