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Quality Specialist - Vacaville, United States - Teamware Solutions a division of Quantum Leap Consulting Pvt. Ltd
Description
TECHNICAL/FUNCTIONAL SKILLS:
· 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.
EXPERIENCE REQUIRED:
· 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
· 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