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Dulce Diaz Quiroz

@dulcediazquiroz

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Quality control specialist with 10+ years in pharmaceuticals.

Mexico

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What I'm looking for

I seek a role that fosters continuous improvement and values quality in pharmaceutical processes.

I am a quality control specialist with over a decade of cross-functional experience in the pharmaceutical industry. My expertise spans safety case processing, complaint investigation, regulatory inspections, global pharmacovigilance operations, and quality control. I have a proven track record of optimizing workflows using LEAN and Six Sigma methodologies, which has significantly enhanced quality systems and contributed to global pharmacovigilance operations.

In my current role as a Specialist Quality Complaints at Tata Consultancy Services, I process medical device complaints and ensure compliance with local and international pharmacovigilance regulations. My efforts have led to a 15% reduction in processing time through effective LEAN workflow optimization. Previously, as Laboratory Chief at Pisa Farmacéutica, I oversaw physicochemical analysis and managed CAPAs, customer complaint resolutions, and non-conformance investigations, participating in over 25 successful audits with no critical findings.

My academic background includes a Doctoral Degree in Biochemistry and a Professional Certificate in Pharmacovigilance, complemented by a Diploma in Black Belt Six Sigma. I am passionate about maintaining high-quality standards and continuously improving processes to ensure patient safety and compliance.

Experience

Work history, roles, and key accomplishments

Current

Specialist Quality Complaints

Current

Tata Consultancy Services

Jan 2024 - Present (1 year 6 months)

Processes medical device complaints and closes related investigations in a timely manner, ensuring compliance with local and international PV regulations and SOPs. Contributed to a 15% reduction in processing time through LEAN workflow optimization. Collaborates remotely with cross-functional global teams to ensure quality and timely safety data reporting.

SOPs Lean Workflow Optimization Quality Control

Laboratory Chief

Pisa Farmacéutica

Jan 2022 - Present (3 years 6 months)

Oversaw physicochemical analysis of medical devices and drugs, ensuring compliance with applicable regulations such as CFR 21, USP, ISO, and ICH. Managed CAPAs, customer complaint resolutions, and non-conformance investigations. Participated in over 25 successful internal and external audits with no critical findings.

Medical Devices Drugs Regulatory Compliance CAPA Auditing

Laboratory Supervisor

Pisa Farmacéutica

Jan 2019 - Present (6 years 6 months)

Managed GxP-compliant lab operations and trained a team of 16 analysts in pharmacopoeial and statistical methods. Authored and implemented SOPs, CAPAs, and deviation investigations. Reduced Out of Specification (OOS) results by 25% via Six Sigma implementation and continuous training.

Statistical Methods SOP Development CAPA Six Sigma Trend Analysis Patient Safety

Research and Development Team Leader

IBt-UNAM

Jan 2018 - Present (7 years 6 months)

Supervised postgraduate researchers in an industry-academia biotechnology project aimed at substituting plant-derived raw materials for biotechnology products. Designed and executed genetic engineering experiments, organic synthesis, and biomolecular characterization.

Biotechnology Genetic Engineering Biomolecular Characterization

Quality Control Chemist

SIGNA S.A. DE C.V.

Jan 2012 - Present (13 years 6 months)

Conducted chemical analysis of raw materials, in-process, and final APIs in compliance with QA standards. Operated various analytical instruments including IR, UV-Vis, AA, fluorescence spectroscopy, and gas/liquid chromatography.

APIs Quality Assurance UV Vis AA Spectroscopy Gas Chromatography

University Professor

UAEMex

Jan 2012 - Present (13 years 6 months)

Actively involved in creating, evaluating, and updating course content material for undergraduate courses in Metabolic Chemistry and Biochemistry. Served as a member of the Scientific Review Committee in conferences and undergraduate evaluations.

Biochemistry Curriculum Evaluation Scientific Review Teaching

Education

Degrees, certifications, and relevant coursework

DNASYS

Professional Certificate, Pharmacovigilance

Obtained a professional certificate in Pharmacovigilance. This program likely focused on the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

ITESO

Diploma, Black Belt Six Sigma

Completed a Diploma in Black Belt Six Sigma. This certification indicates expertise in advanced Lean Six Sigma methodologies for process improvement and quality management.

IBt-UNAM

Doctoral Degree, Biochemistry

Earned a Doctoral Degree in Biochemistry. This advanced degree involved in-depth research and study in the field of biochemistry.

CINVESTAV-IPN

Master's Degree, Biochemistry

Obtained a Master's Degree in Biochemistry. This program provided advanced knowledge and research skills in the biochemical sciences.

UAEMex

Bachelor of Science, Chemistry

Completed a Bachelor of Science degree in Chemistry. This undergraduate program provided foundational knowledge in chemical principles and laboratory techniques.