Sandra Iser
Senior QA Compliance Expert - Audit, Inspection and Incident Management at Novartis | Basel, Basel, Switzerland
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Sandra Iser currently serves as a Senior QA Compliance Expert at Novartis, where she plays a pivotal role in ensuring the integrity and compliance of the company's pharmaceutical operations through comprehensive audit, inspection, and incident management strategies. In her current role, Sandra leads complex health authority inspections, coordinating with regulatory agencies to facilitate smooth and successful audits. Her expertise as a Certified GMP Auditor allows her to meticulously evaluate manufacturing processes, quality systems, and documentation to uphold the highest standards of Good Manufacturing Practice (GMP). She also oversees internal and external audits, including those conducted by notified bodies and customers, ensuring that all activities align with regulatory requirements and Novartis’ internal quality policies.
Sandra’s responsibilities extend to local self-inspection oversight, where she ensures continuous compliance through proactive quality assessments and audits. Her proficiency in quality incident management enables her to swiftly identify, investigate, and resolve deviations, minimizing risks to product quality and patient safety. She actively manages the implementation and maintenance of the Quality Management System (QMS), including documentation management, APR/PQR reporting, and Key Quality Indicators (KQIs), fostering a culture of continuous improvement. Additionally, her expertise in third-party management and quality agreements ensures that external partners adhere to Novartis’ rigorous quality standards. With a strong focus on data integrity oversight, Sandra guarantees that data used for decision-making is accurate, complete, and compliant with industry regulations. Her innovative approach, combined with her deep industry knowledge and certifications, makes her a vital asset in maintaining Novartis’ reputation for quality and compliance in the pharmaceutical industry.
Senior QA Compliance Expert - Audit, Inspection and Incident Management at Novartis in November 2019 to Present
QA Compliance Expert - Quality Management Systems at Novartis in June 2017 to October 2019
Validation Expert - Quality Control Coagulation / Global Quality Assay LCM at Shire in May 2015 to May 2017
Quality Control Expert at Baxter International Inc. in July 2011 to April 2015
Quality Control Expert at InterCell in June 2009 to June 2011
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IMC Fachhochschule, DI, November 2026
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Certified GMP Auditor
Inspektion
Certified Lead Auditor
GMP
Qualitätskontrolle
Validation
Qualitätssicherung
Qualitätsmanagement
Compliance
Microsoft Office
Audit-Management
Data Integrity
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Discover more about NovartisWhat is Sandra Iser email address?
Email Sandra Iser at [email protected] and [email protected]. This email is the most updated Sandra Iser's email found in 2026.
How to contact Sandra Iser?
To contact Sandra Iser send an email to [email protected] or [email protected]. (updated on April 11, 2025)
What company does Sandra Iser work for?
Sandra Iser works for Novartis
What is Sandra Iser's role at Novartis?
Sandra Iser is Senior QA Compliance Expert - Audit, Inspection and Incident Management
What is Sandra Iser's Phone Number?
Sandra Iser's phone (**) *** *** 437
What industry does Sandra Iser work in?
Sandra Iser works in the Biotechnology industry.
Sandra Iser Email Addresses
Sandra Iser Phone Numbers
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