• Us Citizen

• Green Card

• EAD (OPT/CPT/GC/H4)

• H1B Work Permit

• Corp-Corp

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 9th Sep 2021

Skill : Pharma Manufacturing/Research, Computer System Validation, Reliance ETQ

• 10+ years of Business analyst experience in research, development, or manufacturing function of pharmaceutical companies. At least 3+ years of experience in Pharma quality management systems like Risk/Complaints/Audit management, etc.

• Experience using ETQ Reliance QMS preferred. Experience with TrackWise, Veeva or other QMS solutions would be a plus

• Hands on experience with building Requirement Specification, Data mapping, Validation documentation, Operational Qualification Protocols, Performance Qualification protocols., SOPs, Work Instructions.

• Experience around SDLC documentation applicable to Life sciences

• Knowledge of pharmaceutical/medical device regulations like GxP, FDA 21 CFR Part 11, 210, 211.

• Ability to interact with business and IT stakeholders and bring in best practices in Pharma manufacturing.

• Strong understanding of quality management systems & operations with an ability to fill the gap between business users and technologists

• Ability to work independently with minimal supervision.

• Ability to plan for, coordinate, and conduct reviews of project deliverables for completeness, quality, and compliance with established project standards