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Opening for Veeva Vault Platform at Remote, Remote, USA
Email: [email protected]
From:

Dinesh,

kk Associates

[email protected]

Reply to: [email protected]

Hi ..

This is Dinesh from kkassociates, Below Position is Immediate Position from the Client Kindly share Suitable resumes to [email protected].

Veeva Vault Platform

location:
San Francisco, CA

Hire Type: Contract

JD;

1. Provide consulting, author proposals, design, build, Configure and support Veeva QMS, Veeva Vault based applications to meet business process and application requirements

2. 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, CAPAs,Change controls, qualification document review and compliance

4. 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 cross-functional 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 on-going 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 documentation

12. Solves a range of straightforward problems through knowledge and technical experience in own discipline with a moderate level of guidance

13. Support periodic reviews of the entire system and compile related reports during operation phase

14. 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

Thanks & Regards,

Dinesh

Technical Recruiter

KK Associates LLC

Phone : 614-379-0183 |Fax: (614) 413-3428

www.kksoftwareassociates.com

Linkedin:

linkedin.com/in/dinesh-kumar-87b83320b

Keywords: information technology procedural language California
Opening for Veeva Vault Platform
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Tue May 21 04:14:00 UTC 2024

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Location: San Francisco, California