Evangelina Perez Email & Phone Number | PROFILE -30 years plus of combined experience in Pharmaceutical and Medical Device regulated industries -Regulatory Compliance Professional: Regulatory Affairs Certified, ASQ Certified Quality Auditor and Pharmaceutical Quality Assurance Certified Professional. -In-depth knowledge of CGMP, QSR 820, EU GMP / MDD and ISO 13485, Part 11, 21CFR 211, GCP, GLP regulations, ICH Guidelines, ANVISA, JPAL, TGA, PAHO and WHO guidelines and regulations. -Responsible for interpretation and application of local, regional, national and international regulations for the development of policies and standard and the assessment of regulatory compliance -Experienced in the development and manufacturing of medical devices, solid, semi-solid (ointment and creams) and liquid dosage forms as well as sterile/ aseptic drug products, biotech drugs, and active pharmaceutical ingredients. -Responsible for oral and written communications with regulatory agencies and notified body (ISO Registrar). Field Alert Reporting and Recall Coordinator -Contributor and /or responsible for assembly of IND, NDA, DMF, and Site Master File for drugs; and IDE, PMA and/ or 510K for medical devices -Knowledgeable of Risk Management, FMEA, Lean 6-Sigma Principles. -GMP, Quality Culture and Change Management Trainer

Evangelina Perez

PROFILE -30 years plus of combined experience in Pharmaceutical and Medical Device regulated indus...
2739 Waterway Drive, Grand Prairie, United States

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Evangelina Perez’s Email evangelina.perez@alconlabs.com

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Evangelina Perez’s Location 2739 Waterway Drive, Grand Prairie, United States

Evangelina Perez’s Current Industry Alcon A Novartis Comapny

Evangelina Perez’s Prior Industry Allergan

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Work Experience

Alcon A Novartis Comapny

Associate Director, Quality, Compliance

2009-12-01 00:00:00 - Present

Allergan

Sr. Manager QA, Compliance

2007-08-01 00:00:00 - 2009-12-01 00:00:00

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FAQ About Evangelina Perez

Evangelina Perez is located at
2739 Waterway Drive, Grand Prairie, United States

Evangelina Perez is a PROFILE -30 years plus of combined experience in Pharmaceutical and Medical Device regulated industries -Regulatory Compliance Professional: Regulatory Affairs Certified, ASQ Certified Quality Auditor and Pharmaceutical Quality Assurance Certified Professional. -In-depth knowledge of CGMP, QSR 820, EU GMP / MDD and ISO 13485, Part 11, 21CFR 211, GCP, GLP regulations, ICH Guidelines, ANVISA, JPAL, TGA, PAHO and WHO guidelines and regulations. -Responsible for interpretation and application of local, regional, national and international regulations for the development of policies and standard and the assessment of regulatory compliance -Experienced in the development and manufacturing of medical devices, solid, semi-solid (ointment and creams) and liquid dosage forms as well as sterile/ aseptic drug products, biotech drugs, and active pharmaceutical ingredients. -Responsible for oral and written communications with regulatory agencies and notified body (ISO Registrar). Field Alert Reporting and Recall Coordinator -Contributor and /or responsible for assembly of IND, NDA, DMF, and Site Master File for drugs; and IDE, PMA and/ or 510K for medical devices -Knowledgeable of Risk Management, FMEA, Lean 6-Sigma Principles. -GMP, Quality Culture and Change Management Trainer