GxP Auditor

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🕒 vor 2 Monaten

🌲 Oregon – Remote

🌲 Oregon – Remote

⏰ Vollzeit

🟠 Senior

🔴 Experte

🔎 Auditor

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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RxCloud

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2020

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

RxCloud ist ein führender Anbieter von Qualitätsmanagement- und Regulierungsdienstleistungen mit Fokus auf den Lebenswissenschaftssektor, einschließlich Pharmazeutika, Biotechnologie und Medizinprodukte. Mit über 1000 Jahren kombinierter IT- und Branchenexpertise, spezialisiert sich RxCloud auf ein breites Spektrum an Dienstleistungen wie GxP-Audits, Qualitätsmanagement-Beratung und IT-Systemvalidierung. Sie legen Wert auf Effizienz, Compliance und Innovation und unterstützen ihre Kunden dabei, im komplexen Regulierungsumfeld zu navigieren, während sie hohe Qualitätsstandards in ihren Abläufen beibehalten.

Beschreibung

• Function as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations. • Develop and implement the global audit strategy, aligning with organizational goals and regulatory requirements. • Perform audits across various departments and functional areas. • Conduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures. • Review and assess the effectiveness of internal controls, making recommendations for improvement to mitigate risks and strengthen processes. • Collaborate with cross-functional teams, including finance, operations, compliance, and legal, to ensure audit findings are addressed and resolved. • Conduct investigations into allegations of fraud, unethical practices, or non-compliance, and recommend appropriate actions to address such issues. • Prepare comprehensive audit reports, including findings, recommendations, and action plans for management and key stakeholders. • Responsible for leading, conducting, and documenting investigations relating to audit findings noted internally. • Utilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of noted findings. • Ensure audits are performed within budget and according to plan. • Facilitate post-audit debriefs with internal stakeholders within defined timeframes ensuring clear communication of audit findings. • Produce draft and final versions of audit plans, reports and summaries within defined timeframes and accordance with internal policies / procedures. • Promote continual improvement regarding stakeholder satisfaction with emphasis on Quality/GxP auditing services. • Stay current with advances and technological changes in Quality/GxP services within the biotech industry and promote those that will increase effectiveness and knowledge.

🎯 Anforderungen

• Minimum bachelors degree in any scientific discipline. • A minimum of 20 years of relevant experience including a minimum of 15 years of GxP. auditing in a regulated environment focused on quality. • Excellent knowledge of GxP regulatory requirements. • Experience using electronic Quality Management Systems. • Ability to manage multiple projects in a fast-paced environment. • Ability to collaborate effectively in a dynamic, cross-functional matrix environment. • Ability to understand when issues require escalation to Senior Quality Management. • Must be detail oriented; must be precise and organized in handling of documents. Solid organizational skills required; must be able to prioritize multiple tasks.