The purpose of this position is to lead, review, and contribute to validation planning, risk assessment, system requirements formulation, design specifications, test protocol, and applicable remediation efforts associated with software systems. The person will act as a cross-functional, inter-business unit resource. As such, the incumbent must be technically competent in multiple disciplines including quality, information technology, engineering, operations, and GxP systems.
Principal Duties and Responsibilities:
Ensure all software validation and verification activities are in compliance with corporate, QRS, ISO and other regulatory compliance requirements.
Generate and execute software validation plans, risk assessments, test protocols and reports associated with new or revised QMS and commercial off-the-shelf (COTS) software platforms.
Serve as a hands-on Validation Lead for new and changes to existing validated software systems.
Execute, confirm and document test results, when required to do so.
Perform periodic review of validated software systems to ensure compliance to applicable regulatory and quality requirements are maintained.
Maintain validation schedules and applicable key performance indicators.
Assist with audits, explaining software validation and qualification activities performed at the site.
Lead activities associated with the identification and evaluation of new cross-functional software platform solutions.
Develop project plans associated with the implementation of new software platform solutions based on existing regulatory and compliance requirements.
Expected Areas of Competence:
Proven ability to execute all phases of a software validation.
Knowledge of 21 CRF Part 11 Electronic Records, Electronic Signatures.
Knowledge of ISO 13485: Section 4.1 General Requirements; Section 7.5.6 Validation of processes for production and service provision requirements.
Knowledge of 21 CFR Part 820 Section 820.70 Production and Process Controls.
Proven ability to write technical documentation including validation protocols, FMEA's, test scripts, test reports.
Proven ability to write analytical methods requirements and tests.
Able to lead and prioritize tasks and to drive projects to completion.
Ability to communicate in a clear, concise manner including previous experience in writing technical documentation.
Able to work in a team environment.
Possess strong organizational and interpersonal skills.
Bachelor of Science degree in relevant field (science, engineering, etc.)
5 - 7 years related experience or equivalent combination of education and experience.
Medical device experience preferred.