Job Description :
Job Title IT Systems Validation
Project Location Lebanon, NH
Duration 6+ Months Contract
Interview Mode: Phone + Skype
Must haves- GxP/GMP experience in BioPharma domain. Validation experience
Key Responsibilities:
This role will be responsible for monitoring day-to-day usage operation and maintenance of computer systems. Job responsibilities include but are not limited to implementing and maintaining controls, processing and documentation to provide: confidentiality, integrity, availability, compliance and reliability of computer systems to support business operations.
Main Job Tasks:
Facilitate the seamless transition and handover of Projects with key stakeholders.
o Maintain system documentation and process according to client standards and in compliance with regulatory requirements in a structured way to facilitate rotation and consequently transition of systems from System Manager to System Manager.
o Work in partnership with project managers to define interface agreements, SLAs and proper change management to move systems to operations.
o Provide active/effective engagement, planning, communication and stakeholder management to transition of System Management roles and responsibilities from LoB.
Support daily IT Operations including but not limited to: general support; vendor management; change and release management; archiving and retention of computer system documentation and data; risk management and security; validation and training.
o Provide follow-up on Incidents, Service Requests, Problems, Change Requests and Remarks/NCs. Ensure communication, action and escalation on issues that impact system Confidentiality, Integrity, Availability, Compliance and Reliability.
o Maintain list of IT vendors/suppliers including the criticality of the hardware, software and critical infrastructure for computer systems.
o Develop and negotiate vendor Service Level Agreements regarding system support.
o Follow-up on vendor deliveries and services according to agreements.
o Maintain SLA’s and IT Service catalog.
o Ensure proper documentation, testing, communication and stakeholder management for changes.
o Provide continuous follow-up on system component life-cycle ensuring proper maintenance and system strategy.
o Archive and retain documentation and data according to requirements.
o Facilitate risk management work in cooperation with stakeholders and department manager.
o Maintain disaster recovery documentation and proper test and training of stakeholders.
o Maintain required controls to ensure system security.
o Ensure that the systems are in compliance with relevant internal and external requirements (cGMP, 21CFR Part 11 and overall instructions)
o Participate in audits and inspections and provide the needed documentation to demonstrate validation state and proper management of the systems though the life-cycle.
o Create and maintain system documentation for GxP computer systems.
o Test IT requirements for GxP computer system
o Perform, prepare and maintain training material, including but not limited to SOPs, Guidelines and class training material.
o Ensure proper planning, communication and documentation to retire systems according to requirements and regulations.
Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.