Quality Expert, Computerized System Validation

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 ValidationKnowledge, 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.+ Ability to complete work quickly and efficiently.+ Critical and innovative thinker.+ Ability to understand multiple perspectives.+ Inquisitive and eager to learn.+ Comfortable with ambiguity.+ Forward thinking#LI-US