As a pioneer in the development of automated validation software solutions, ValGenesis, Inc. leads the way with a unique paperless validation process that tracks the validation status of any GxP system in real time
ValGenesis Inc. is a rapidly growing software company. ValGenesis was selected by PDA as a New innovative technology for year 2005.Our headquarters is based in Fremont, CA, USA with development center in Ascendas International Tech Park, Taramani, Chennai, Tamil Nadu.
Most of our clients are based in US and Europe.
Validation Engineers - Chennai
10/14/2016 1:27:22 AM
Understand web application application features / requirements and define Validation Strategy, Validation Plan and Validation test cases
Good Understanding in Risk Assessment process
Proficient in Validation Life Cycle Management process
Strong understanding and experience in 21 CFR Part 11 (Electronic Records; Electronic Signatures), EU Annex 11, GAMP 5, etc.
Good skills in authoring validation protocols (Operational Qualification, Configuration verification etc.) and requirement documents
Experience in executing validation protocols.
Extensive knowledge of all the stages of the System Development Life Cycle (SDLC) and conducting reviews of all systems lifecycle deliverables
Should have good analytical and Technical writing skills
Knowledge in Validation Lifecycle process
Strong communication skill in English is a must.
Worked in a Computer System Validation project for Life sciences industry
Sound knowledge in Good Documentation Practices and Quality Management System (QMS).