Veeva Vault Platform- San Francisco CA Onsite
Posted on :
21-05-2024
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Monthly Salary
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Salary Not Disclosed
Posted on :
21-05-2024
Job Description
Hi Professional
I hope you are doing good.
Please find below requirement and let me know your interest
Veeva Vault Platform
Location: San Francisco CA Onsite
Duration: Long term
Role name:
Lead
Role Description:
- Provide consulting author proposals design build Configure and support Veeva QMS Veeva Vault based applications to meet business process and application requirements2. Provide training and support to employees on Veeva QMS as well as on QMS procedures and best practices in general.3. Knowledge on handling events QARs CAPAsChange controls qualification document review and compliance4. Stay updated on industry trends and regulatory changes to ensure continuous compliance.5. Lead the development and execution of QMS processes including document control change management and CAPA (Corrective and Preventive Actions).6. Collaborate with crossfunctional teams to assess and enhance quality processes throughout the product lifecycle.7. Drive continuous improvement initiatives to optimize QMS efficiency and effectiveness.8. Prepare and present reports on quality metrics and compliance status to management.9. Support the ongoing regulatory compliance of the IT components for defined servicesto ensure the proper integration and functionality of the Veeva QMS system.10. Strong project management skills with a focus on delivering results within deadlines.11. Review and approve regulatory system changes and documentation12. Solves a range of straightforward problems through knowledge and technical experience in own discipline with a moderate level of guidance13. Support periodic reviews of the entire system and compile related reports during operation phase14. 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.
Competencies:
Veeva Vault Platform
Experience (Years):
10 & Above
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. Indepth 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
Employment Type
Full Time
Key Skills
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