• 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 :- 4th Feb 2022

 
Experience in software validation IQ, OQ and PQ's, preferably MedTech or Healthcare
Review and approve system validation documents and assure regulatory compliance, GxP guidance documents and alignment with company SOPs and TDR processes.
Review validation documentation for adherence to computer system validation (CSV) protocols, and applicable industry accepted standards.
Develop User Acceptance Testing (UAT) test scripts, execute UAT test plans/cases and provide results to business leads.
Ability to Independently assess and monitor the project validation deliverables compliant to company procedures like mapping business requirements to test plan, etc.
Ensure adherence to the SDLC and IT Change Management processes for IT implementations.
Collaborate with Business SMEs, IT and vendor partners to ensure alignment of business requirements and functional designs for validation.
Report or provide information in response to ad hoc information requests.
Independently managing the validation process for the entire project lifecycle
Prior Experience in Agile methodology for project implementation.
Experience with Veeva or a similar quality system.