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Location: New Hampshire, NH
Sr. BA - IT Systems Validation
Location: New Hampshire, NH
Location: New Hampshire
Duration: 6+ Months
- Maintaining GxP computer systems through the life cycle, in pharmaceutical industries;
- Experience responding to internal and external audits/inspections;
Experience performing assessment and remediation of computer systems
Main Job Tasks:
- Facilitate the seamless transition and handover of Projects with key stakeholders.
- 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.
- Work in partnership with project managers to define interface agreements, SLAs and proper change management to move systems to operations.
- 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.
- 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.
- Maintain list of IT vendors/suppliers including the criticality of the hardware, software and critical infrastructure for computer systems.
- Develop and negotiate vendor Service Level Agreements regarding system support.
- Follow-up on vendor deliveries and services according to agreements.
- Maintain SLA’s and IT Service catalog.
- Ensure proper documentation, testing, communication and stakeholder management for changes.
- Provide continuous follow-up on system component life-cycle ensuring proper maintenance and system strategy.
- Archive and retain documentation and data according to requirements.
- Facilitate risk management work in cooperation with stakeholders and department manager.
- Maintain disaster recovery documentation and proper test and training of stakeholders.
- Maintain required controls to ensure system security.
- Ensure that the systems are in compliance with relevant internal and external requirements (cGMP, 21CFR Part 11 and overall instructions)
- Participate in audits and inspections and provide the needed documentation to demonstrate validation state and proper management of the systems though the life-cycle.
- Create and maintain system documentation for GxP computer systems.
- Test IT requirements for GxP computer system
- Perform, prepare and maintain training material, including but not limited to SOPs, Guidelines and class training material.
- 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.
- Knowledge, Skills and Experience:
- Bachelor’s Degree in Computer Science or equivalent;
- IIBA Certification ECBA or CCBA preferred
- Minimum 5 years’ experience on operation and maintenance of IT systems, preferably within the pharmaceutical industry;
- Experience with validating and qualifying IT systems in GxP and non GxP environments, performing and executing validation documentation and testing protocols (IQ/OQ/PQ/UAT);
- Excellent writing and communication skills
- Strong ability to collaborate effectively in a team environment
- Excellent problem solving, negotiation, conflict management, and interpersonal skills;
- Demonstrated ability to plan, organize, decision make and deal with ambiguity
- Strong computer skills and expert in MS Office