- Develop SDLC and associated CSV validation procedures, templates, and job aids in alignment to regulations and other compliance requirements.
- Prepare training materials and perform training and coaching for all team members.
- Perform validation of products and services and qualification of software/hardware (Clinical SaaS software (customer facing), SDLC tools and other operational enablement software that are internal)
- Manage a continuous improvement backlog for all processes enforced by the SDLC and CSV validation procedures.
- Ensure training gaps, process gaps, audit findings and quality incidents have corrective and preventive actions in place.
- Liaison with business, technical and other compliance stakeholders to ensure the SDLC procedures and associated templates work as intended to enforce compliance at all levels.
- Participate in remediating audit findings and quality incidents.
- Well versed with GxP validation protocols aligned to US FDA CFRs particularly CFR Part for electronic records and electronic signatures and EU guidelines including Annex .
- Hands on experience validating cloud applications including portals, websites, and mobile applications.
- Experience validating systems that are AI/Client products in itself or use AI/Client components.
- Strong focus on risk assessment and validation of parameters impacting patient safety, product quality and data integrity.
- Ability to perform regulatory interpretation as and when required and provide data and clarifications.
- Be able to develop metrics to assess validation throughput, record and follow up on non-conformances as well as CAPA from product requirement initiation to launch.
- Experience ensuring audit readiness and leading audits
- Experience in audit readiness for FedRAMP certification
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Senior Validation Consultant - Rockville, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:Requirements:
