Sergio Richard Wolff Ms Cqa

Experienced analytical chemist, chemical engineer and quality executive with over 20 years of cGMP experience in pharmaceuticals, biotech,... | North Haven, Connecticut, United States

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Sergio Richard Wolff Ms Cqa’s Emails sw****@in****.com

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Sergio Richard Wolff Ms Cqa’s Location North Haven, Connecticut, United States

Sergio Richard Wolff Ms Cqa’s Expertise 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.

Sergio Richard Wolff Ms Cqa’s Current Industry Alexion Pharmaceuticals

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Work Experience

Alexion Pharmaceuticals

Sr. Auditor , Global GxP Audit Quality

Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Invicro

Director of Chemistry QA

Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Wave Life Sciences

Manager, External Quality & Compliance

Mon Feb 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Avista Pharma Solutions Now Part Of Cambrex

Sr. Director Quality Assurance

Tue Jan 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

American Distilling

Director of Quality and Regulatory Affairs

Tue May 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Pharmasol

VP Quality and Regulatory Affairs

Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Independent Consulting

Sr Pharmaceutical Consultant

Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

University Of Rhode Island

Head of Quality, cGMP Facility (part time)

Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)

Perrigo

Director QA/QC

Thu Jan 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)

Teva Pharmaceuticals

Senior Manager Quality Technical Services

Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)

Abbott Labs

Manager Product Assurance (Stability)

Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)

United States Army Reserve

E4 -Technical Support Engineer

Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)

Purdue Pharma

Sr. Chemist and Supervisor

Sat Jan 01 1994 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time)

Sanofi Aventis

Method Development Chemist

Fri Jan 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 1994 00:00:00 GMT+0000 (Coordinated Universal Time)

Becton Dickinson

R&D Chemist

Wed Jan 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

Languages

Sergio Richard Wolff Ms Cqa Email Addresses

sw****@in****.com Work Email

sw****@in****.com Personal Email

se****@ca****.com Personal Email

FAQ About Sergio Richard Wolff Ms Cqa

Sergio Richard Wolff Ms Cqa is located at
North Haven, Connecticut, United States

Sergio Richard Wolff Ms Cqa is a
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. Alexion Pharmaceuticals

Sergio Richard Wolff Ms Cqa currently works in the
Alexion Pharmaceuticals

Sergio Richard Wolff Ms Cqa specializes in
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.

Sergio Richard Wolff Ms Cqa speaks the following languages:
No languages available.

Sergio Richard Wolff Ms Cqa has prior experience in the following industries:
Invicro , Wave Life Sciences , Avista Pharma Solutions Now Part Of Cambrex , American Distilling , Pharmasol , Independent Consulting , University Of Rhode Island , Perrigo , Teva Pharmaceuticals , Abbott Labs , United States Army Reserve , Purdue Pharma , Sanofi Aventis , Becton Dickinson

Sergio Richard Wolff Ms Cqa has the following professional experience:
Alexion Pharmaceuticals , Invicro , Wave Life Sciences , Avista Pharma Solutions Now Part Of Cambrex , American Distilling , Pharmasol , Independent Consulting , University Of Rhode Island , Perrigo , Teva Pharmaceuticals , Abbott Labs , United States Army Reserve , Purdue Pharma , Sanofi Aventis , Becton Dickinson .