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Veeva QMS Consultant | San Francisco, CA | 6 months | Onsite | C2C
4 months ago
Veeva QMS Consultant | San Francisco, CA | 6 months | Onsite | C2C
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.
- 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.
- Awareness of ITIL and Support Project Methodology.
- 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
Responsibilities:
- 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
