Clinical Audit Support
Arnex Solutions LLC
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Job Details
Skills
- GXP
- Quality System maanger
- GMP Audit
- Clinical/Lifescience
Summary
1. Facilitate audit request process for GP regulatory inspections, customer audits, and internal quality audits
* Develop a strong understanding of Abbie's SLand system evidence to support audits
* Leverage available resources and improve resources to enhance or maintain with changes in environment.
* Coordinate audit support activities with appropriate Abbie system SMEs to tutfilt audit requests; escalate risks and issues, to ensure timely resolution/responses in alignment with agreed SLAs.
* Build relationships with system SMEs to facilitate the audit support process
* Engage in ongoing dialogue with compliance team to identity and obtain alignment on process improvements.
* Drive implementation of process improvements:
* Streamine data collection of audit requests, propose and implement smartsheet updates to minimize site data input white ensuring appropriate data is captured for beneticial analytics
* Review lessons learned to identity challenges and reduce cycle times o identity opportunities to increase self-service portal usage.
* Faudit request data
* internal quality audit observations
externat inspection data, including observations and warning letters, using available sources, e.g.Redica
identity potential gaps/remediation needs; establish cadence and format to share insights o improvement opportunities (proactively addressing gaps based on regulatory insights); frame
opportunities for consideration by appropriate Quality System CoE
propose continuous improvement (Ci) initiatives and execute initiatives to completion
4. Maintain self-service portat tinks, ensuring current evidence is published.
5. Continuous Improvement
* Use technology, automation, and Alto implement enhancements to audit request platform and audit sell-service capabilities
* Monitor feedback and propose expansion of capabilities and improvements
6. Status Reporting
Provide weekly status reporting
- Dice Id: 91124621
- Position Id: 301-38988-2567
- Posted 16 hours ago
Company Info
About Arnex Solutions LLC
At Arnex Solutions LLC, we go beyond traditional consulting. We blend expertise with innovation to offer end-to-end solutions that bridge the gap between business challenges and technological advancements.
Our Services:
Strategic IT Advisory: Our experienced consultants collaborate with you to craft customized IT strategies that drive growth and efficiency. We transform technology into a competitive advantage.
Talent Resourcing: Access top IT talent with ease. Our staffing solutions connect you with skilled professionals who align with your unique business requirements.
Cloud Excellence: Leverage the power of the cloud with our tailored services. From strategy to execution, we help you harness cloud capabilities for innovation and scalability.
Why Choose Arnex Solutions LLC:
Holistic Approach: We're your all-in-one partner for both strategic consulting and talent acquisition. Our holistic solutions ensure your business stays ahead in a dynamic landscape.
Client-Centric Philosophy: Your success is at the heart of everything we do. Our collaborative approach ensures we understand your unique needs and deliver impactful solutions.
Innovation Infused: We embrace emerging technologies to drive innovation. Partnering with Arnex Solutions LLC means accessing solutions that position you for sustained success.
Enduring Partnerships: Our commitment extends beyond a single project. When you choose Arnex Solutions LLC, you choose a partner dedicated to your long-term growth.
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