Hawkins Point Partners is looking for an IT Quality & Validation Analyst to play a key role on our client's IT Quality & Regulatory Compliance team. The IT Quality Analyst helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT systems.
Roles and Responsibilities
This job requires the IT Quality Analyst to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The IT Quality Analyst must maintain a professional manner in representing the company and in working with its agents and associates. The individual should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.
7+ years IT Quality / Validation experience in computerized system validation within a regulated environment preferably R & D application.
Thorough knowledge of GxP and ERES (21CFR Part 11 and Annex 11) regulations and guidelines
Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment
Thorough knowledge of IT Controls methodologies, including GAMPS and ITIL
Experience with risk analysis and risk management practices and tools
Excellent communication skills, both verbal and written
Knowledge of general software, database concepts and Data Integrity
Knowledge of infrastructure technology and platforms
The ability to work both independently and with teams
Does this sound like something you are interested in?? Apply today!
About Hawkins Point Partners
At Hawkins Point Partners, we understand the value and structure that documented processes can bring to a young IT department, as well as provide guidance to an established group climb to the right level on the maturity scale. To accommodate, we offer assessment of IT Quality Management System (IT QMS), developing and implementing a roadmap to get to the right level of maturity, while balancing costs with compliance.