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:
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Bachelor’s Degree with a +5 years of experience in Computerized System Validation or equivalent work experience in healthcare industry. Master's degree preferred.
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Operational experience in quality processes supported by computerized systems, particularly in the healthcare industry.
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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:
- Bachelor’s degree with +5 years of experience in Computerized System Validation
Knowledge, Skills & Abilities:
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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
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