What are the responsibilities and job description for the QUALITY EXPERT, COMPUTERIZED SYSTEM VALIDATION position at BioFire Diagnostics, LLC.?
Primary Duties :
Project and RUN Activities for the Information Systems (IS) Department :
Participate in IS delivery with regulatory implications.
Work closely with various members of the IS team members to provide the necessary quality and regulatory support for project / program execution.
Conduct functional and regulatory risk analyses.
Develop and implement validation strategies for Non-Product Software (NPS),
Contribute to the Change Control process by challenging and validating impact analyses.
Participate in periodic reviews to ensure the validated status of implemented solutions.
Actively contribute to the improvement of IS processes to adapt to user needs and regulatory requirements.
Monitor Key Performance Indicators.
Cross-functional Activities :
Develop and Deliver trainings on Non-Product Software Validation.
Provide expertise and necessary advice to local entities for NPS validation and maintenance of validated status.
Act as a key participant in the continuous improvement of NPS validation processes and methods at corporate level.
Training and Education :
Bachelors Degree with a 5 years of experience in Computerized System Validation or equivalent work experience in healthcare industry. Master's degree preferred.
Operational experience in quality processes supported by computerized systems, particularly in the healthcare industry.
Experience in implementing digital and XaaS solutions is an advantage .
Expert in the implementation of GAMP (Good Automated Manufacturing Practices).
Advanced knowledge of regulations and standards applicable to software development (such as 21 CFR Part 820, 21 CFR Part 11, ISO9001, and ISO13485).
Conducting audits on regulatory aspects and standards would be a plus.
Pragmatic, autonomous, rigorous, and demonstrate the ability to synthesize information and have good interpersonal skills, with a strong capacity for listening and advising.
Fluency in English, both spoken and written, is mandatory.
Experience :
Bachelors degree with 5 years of experience in Computerized System Validation
Knowledge, Skills & Abilities :
Requires computer skills including Microsoft Office Package (Excel, Word, etc)
Must possess strong interpersonal, written, and oral communication skills.
Self-motivated, and able to manage time effectively.
Critical listening skills, and an ability to recognize important and high-level information.
Ability to stay positive and calm in stressful situations.
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