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Daniel VHDV
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Daniel VH

@danielvh

Quality assurance specialist driving compliance, audits, and continuous improvement.

United States
Message

What I'm looking for

I seek a quality-focused role where I can lead audits, enforce compliance, improve processes, mentor teams, and contribute to regulatory-ready manufacturing environments.

I am a dedicated quality assurance professional with extensive experience in manufacturing and pharmaceutical quality systems, auditing, and regulatory compliance. I lead batch record reviews, internal and external audits, and liaise with regulatory agencies to ensure cGMP and industry standard adherence.

My background includes deviation management, root cause analysis, and cross-functional collaboration supporting biologics and vaccine manufacturing. I have implemented quality management systems, overseen change control and documentation, and used tools like Veeva Vault, Oracle, and Tableau to support quality operations.

I also bring leadership experience managing teams, training staff, and driving process improvements that reduce defects and ensure product integrity. I pursue continuous improvement and practical solutions that align quality with operational goals.

Experience

Work history, roles, and key accomplishments

CA
Current

Quality Assurance Specialist

Catalent

Jun 2022 - Present (3 years 6 months)

Lead batch record review and approval ensuring cGMP and regulatory compliance (ISO 9001, ISO 13485, AS9100, 21 CFR) and managed internal/external audits to drive continuous quality improvements.

AL

Quality Control Inspector III

Almac

Feb 2016 - Jan 2020 (3 years 11 months)

Performed incoming/outgoing inspections, managed non-conformances and documentation, and recommended process improvements to reduce defects and ensure product conformance.

Education

Degrees, certifications, and relevant coursework

Temple University, Fox School of Business logoTB

Temple University, Fox School of Business

Bachelor of Business Management, Management Information Systems

Completed a Bachelor of Business Management with a focus in Management Information Systems and a minor in Biomedical Sciences.

Tech stack

Software and tools used professionally

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Daniel VH - Quality Assurance Specialist - Catalent | Himalayas