Sergio Richard W.
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Sergio Richard W. Email & Phone Number

Sr. Auditor , Global GxP Audit Quality ARDU at AstraZeneca
Location: North Haven, Connecticut, United States 16 work roles 4 schools
1 work email found @wavelifesci.com LinkedIn matched
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Current company
Role
Sr. Auditor , Global GxP Audit Quality ARDU
Location
North Haven, Connecticut, United States
Company size

Who is Sergio Richard W.? Overview

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Quick answer

Sergio Richard W. is listed as Sr. Auditor , Global GxP Audit Quality ARDU at AstraZeneca, a company with 1001 employees, based in North Haven, Connecticut, United States. AeroLeads shows a work email signal at wavelifesci.com and a matched LinkedIn profile for Sergio Richard W..

Sergio Richard W. previously worked as Sr. Auditor , Global GxP Audit Quality at Alexion Pharmaceuticals, Inc. and Director of Chemistry QA at Invicro. Sergio Richard W. holds Phd Candidate, Pharmaceutical Sciences from University Of Rhode Island.

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Email format at AstraZeneca

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*@wavelifesci.com
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Profile bio

About Sergio Richard W.

Experienced analytical chemist, chemical engineer and quality executive with over 20 years of cGMP experience in pharmaceuticals, biotech, nutritionals, medical devices and compounding pharmacy.Specialties:Executive site quality management including QC, QA , stability, investigations, CAPA, change control, specifications, raw material/supply chain management.Quality Systems design, implementation and validation for cGMP manufacturing.Analytical research, development and validation.Internal and external auditing, third party/CMO management, compendia liaison.Data integrity and forensic data investigations.Stability programs for commercial and clinical trail stage (phase appropriate) GMP/GLP . Pharmaco-economics applied to quality functions : cost benefit analysis for QMS implementations, general cost of quality determination, standard hours etc.

Listed skills include Chromatography, Variance Analysis, Clinical Trials, Specifications, and 269 others.

Current workplace

Sergio Richard W.'s current company

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AstraZeneca
Astrazeneca
Sr. Auditor , Global GxP Audit Quality ARDU
North Haven, CT, US
Website
Employees
1001
AeroLeads page
16 roles · 34 years

Sergio Richard W. work experience

A career timeline built from the work history available for this profile.

Sr. Auditor , Global Gxp Audit Quality Ardu

North Haven, CT, US

Sr. Auditor , Global Gxp Audit Quality

Current

Boston, Massachusetts, US

Key responsibilities: lead, and report independent audits of GMP/GDP sites (internal and suppliers) ranging from biotechnology, material manufacturers, laboratories, combination product, to distributors.

Feb 2024 - Present

Director Of Chemistry Qa

Needham, MA, US

Accountable for approval process of all radiopharmaceutical production batch records (small and large molecule precursors) and adherence to process and GMP regulations, Sterility Assurance, and technical specification prior to dosing.

Mar 2023 - Feb 2024

Manager, External Quality & Compliance

Cambridge, Massachusetts, US

Feb 2021 - Mar 2023

Director Of Quality And Regulatory Affairs

American Distilling Inc
May 2018 - Jan 2019

Vp Quality And Regulatory Affairs

South Easton, One Norfolk Avenue, US

Ensuring corporate cGMP compliance for all commercial and developmental activities.

2017 - 2018 ~1 yr

Sr Pharmaceutical Consultant

Independent Consulting

Senior ConsultantClients included Pharmedium, Patheon, University of Rhode Island, Fresenius, J&J, Apotex, Hospira, Rhode Island State Health DepartmentSupplier Quality Systems, Investigation/Deviations/CAPA, FDA Warning Letter remedial actions, Change Controls, Specifications, Master Validation Plan, cGMP Facility DQ/IQ/OQ, QA oversight of new cGMP.

2012 - 2017 ~5 yrs

Head Of Quality, Cgmp Facility (Part Time)

Kingston, RI, US

Designing and Implementing all required Quality Systems for cGMP manufacturing for a start-up pharma/biotech pilot plant (ISO 5-8).Managing and supervising all validation activities and late-stage construction remediation.

2012 - 2015 ~3 yrs

Director Qa/Qc

Dublin, County Dublin, IE

Initially PBM Nutritionals (former Wyeth Nutritionals), acquired by Perrigo in 2010.Directing all aspects of analytical & microbiological testing for QC and Analytical Development functions.Directing and managing disposition of finished product and ingredients, stability programs and analytical assistance for product development/R&D.

2009 - 2011 ~2 yrs

Manager Product Assurance (Stability)

Abbott Park, Illinois, US

former Knoll Pharma, division of BASFCedar Knolls, New Jersey from 1999-2001 Whippany, New Jersey 2001-2005

1999 - 2005 ~6 yrs

Sr. Chemist And Supervisor

Stamford, CT, US

aka PF Labs, Totowa New Jersey

1994 - 1999 ~5 yrs

Method Development Chemist

Paris, France, FR

former Hoechst AG, Rte 202/209, Bridgewater, New Jersey

1993 - 1994 ~1 yr

R&D Chemist

Franklin Lakes, New Jersey, US

Franklin Lakes, New Jersey

1992 - 1993 ~1 yr
Team & coworkers

Colleagues at AstraZeneca

Other employees you can reach at alexion.com. View company contacts for 1001 employees →

4 education records

Sergio Richard W. education

Phd Candidate, Pharmaceutical Sciences

University Of Rhode Island

Mba, Marketing

Montclair State University

Master Of Science, Chemistry

Montclair State University

Bs, Major: Chemical Engineering, Minor : Chemistry

Politehnica University Timisoara
FAQ

Frequently asked questions about Sergio Richard W.

Quick answers generated from the profile data available on this page.

What company does Sergio Richard W. work for?

Sergio Richard W. works for AstraZeneca.

What is Sergio Richard W.'s role at AstraZeneca?

Sergio Richard W. is listed as Sr. Auditor , Global GxP Audit Quality ARDU at AstraZeneca.

What is Sergio Richard W.'s email address?

AeroLeads has found 1 work email signal at @wavelifesci.com for Sergio Richard W. at AstraZeneca.

Where is Sergio Richard W. based?

Sergio Richard W. is based in North Haven, Connecticut, United States while working with AstraZeneca.

What companies has Sergio Richard W. worked for?

Sergio Richard W. has worked for Astrazeneca, Alexion Pharmaceuticals, Inc., Invicro, Wave Life Sciences, and Avista Pharma Solutions - Now Part Of Cambrex.

Who are Sergio Richard W.'s colleagues at AstraZeneca?

Sergio Richard W.'s colleagues at AstraZeneca include David Iannuccilli, Jae-Hwi Sung Ph.D., Sadaf Ansari, Ciara Heuston, and Sandeep Singh Tomar (Eit).

How can I contact Sergio Richard W.?

You can use AeroLeads to view verified contact signals for Sergio Richard W. at AstraZeneca, including work email, phone, and LinkedIn data when available.

What schools did Sergio Richard W. attend?

Sergio Richard W. holds Phd Candidate, Pharmaceutical Sciences from University Of Rhode Island.

What skills is Sergio Richard W. known for?

Sergio Richard W. is listed with skills including Chromatography, Variance Analysis, Clinical Trials, Specifications, Suppliers, Method Transfer, Printing, and Books.

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