Quality Specialist

4 weeks ago

Vacaville, United States Teamware Solutions a division of Quantum Leap Consulting Pvt. Ltd Full time

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

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