Under minimal direction, the Lead Software Validation Analyst will contribute to the full life cycle of software products for a growing Medical Device company. This position is responsible for ensuring the Quality system applications are fully-functional and meets the needs of the End User while ensuring the GxP regulations are met. Good leadership and communication skills are required for team collaboration, testing scenario feedback and time management.
Principal Duties and Responsibilities
Leads high complex software validation projects which align to defined procedures
Performs gap and risk analysis of IT system changes to ensure appropriate testing levels are performed
Works with project teams to develop, review and approve computer systems validation plans, requirement specifications, testing qualification protocols (IQ, OQ, PQ) and final reports for IT systems
Guides testing to ensure the quality of software meets the approved intended use prior to production release
Provides assurance that IT systems remain in a validated state through their life cycle as well as reviews and approves respective change control documents
Trains other personnel to assist in the execution of computer system validation activities
Acts as a cross functional resource and ensures compliance with regulatory and corporate policies and standards
Meets defined deadlines for assigned tasks and scheduled deliverables
Provides mentoring and coaching to junior team members
Applies concepts of appropriate standard methodologies and best practices
Other special projects as needed
Expected Areas of Competence
Knowledge of Medical Device or Pharmaceutical industries desired
Good understanding of the FDA regulations (CFR 21 Part 820, Part 11)
Adequate discipline and professionalism to work diligently within published FDA device regulatory guidelines and internal Standard Operating Procedures
Ability to implement the V-model (GAMP)
Good understanding of testing methodology and software development lifecycle
In depth knowledge of software lifecycle
Highly motivated self-starter with strong attention to detail and proven ability to prioritize and scope work
Excellent verbal and written communication skills
Flexibility to handle demands of a rapidly growing and changing workplace
General wide breadth of knowledge of the different Microsoft Office
Knowledge of HP ALM useful, or other validation approaches desired
Education/Experience Requirements
Bachelor degree in Information Technology, Engineering, Science, or related field with 6+ years related professional experience, or Bachelor and Master's degree with 5+ years related professional experience required
5+ years experience in a FDA regulated industry working on Computerized System Validation (CSV) activities preferred
