• 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 Jan 2021

Job Description: 

* Lead and institutionalize system quality and compliance knowledge (21 CFR Part 11 & GAMP5) on various GxP and enterprise-level system/application implementations for wide array of global business units. 

* Effectively communicate with internal stakeholders and provide internal quality/compliance guidance to assure timely execution of validation initiatives and implementation of information systems. 

* Assesses the compliance/quality of validation approach/strategies as outlined in project-specific validation plans and the Computer Validation Master Plan. 

* Review/Approve validation as well as software development lifecycle (SDLC) documentation including: validation plans, system/software requirements specifications, risk analysis, 21 CFR Part 11 checklists, installation/operational/performance qualifications, configuration management plans, traceability matrices, migration plans/reports, decommissioning plans/reports, user acceptance testing, and validation summary reports. 

* Review/Approve applicable policies, standard operating procedures (SOPs), work practices (WPs), and guidelines specific to change management, release management, defect management, configuration management, document management, backup & restoration, physical/logical security, and validation planning, to ensure compliance with regulatory requirements and industry standards. 

* Review Corrective and Preventative Actions, Change Requests, and Information Technology Investigations to assure proper documentation, completeness, clarity, traceability, and compliance with internal procedures as well as processes. 

* Support the development, maintenance, and implementation of IT quality standards for requirements gathering, system testing, and change controls. 

Requirements: 

* Solid understanding of governing regulatory-body (i.e., FDA, EMEA, MHRA, etc.) quality guidelines and compliance requirements for software/hardware development, testing, and validation. 

* Working knowledge of 21 CFR Part 11, GAMP 5, and PIC/S. 

* Solid experience in the development, implementation, and management of SDLC processes, including knowledge of process improvement. 

* Demonstrated strong organizational, verbal, written, and presentation skills. 

* Highly practical in problem solving and analytical skills. 

* Excellent ability to work on multiple projects with competing priorities. 

* Demonstrated strong inter-personal skills in negotiation, conflict management, and team building.