Perrine Lelievre Email & Phone Number | > 20 years of expertise for biotechnologies, phamaceutical industry, tobacco industry and medical device sector including early career experience in research and quality control laboratory as technical expert and latter success as quality expert involving in several new biopharmaceutical plant building. Extensive knowledge of biologics ( vaccines, cell therapy, injectable ...), non sterile and sterile product manufacturing, testing and clinical trial studies. I am a strong relationship and trust builder as well as solution oriented. I am willing to continuously strenghten and widen my personal knowledge by learning more from new positions and new processes/responsibilites. Specialties: #GxP #sterileconstraints #continuousimprovment #pragmatism #biopharmaceutical #operationsmanagement #leadership #empower #active communication # stakeholdersoriented #consciousness #openpersonality #assertivity ✦ CORE COMPETENCIES: ✦ Quality Assurance QMS SME for implementation of VEEVA Modules Compliance (Deviation-CAPA-Change Control Handling OOS Investigations Handling for Laboratory) Inspection / Audits Certified Auditor. Internal Audits. Regulatory Inspections (FDA, ANSM,...) QA engineering Review CQV, CSV (IQ, OQ, PQ Protocols, Reports, VMP, Risk Analysis). Transfer validation of the manufacturing process for an injectable (upstream and downstream processes) Development and Validation of methods in QC laboratory (Implementation of analytical validation requirements). Maintain qualified equipment and systems in compliance with policies, guidelines, and procedures Conduct investigations into qualification failures and develop and implement remediation plan. ✦ Quality Control ✦ Immunology testing: ELISA Radioactivity (Chrome51), Flow Cytometer (Activity measurement) Western Blot, SDS Page Direct Agglutination method (agglutinins, hemolysins) Ouchterlony Test ✦ Biochemistry testing: Chromatography (CPG, HPLC, CCM) Spectrophotometry Agarose gel electrophoresis, Capillary Electrophoresis ✦ Virology testing Cells Culture

Perrine Lelievre

> 20 years of expertise for biotechnologies, phamaceutical industry, tobacco industry and medical de...
Gilly, Gilly, Switzerland

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Perrine Lelievre’s Email perrinelelievre@wanadoo.fr

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Perrine Lelievre’s Location Gilly, Gilly, Switzerland

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Work Experience

Inlingua Leman

Cambridge First (Fce) Certificate In English

2023-09-01 00:00:00 - 2023-11-01 00:00:00

Innopark Suisse

Training And Coaching

2022-12-01 00:00:00 - 2023-06-01 00:00:00

Cytiva

Quality Assurance Leader

2021-10-01 00:00:00 - 2022-06-01 00:00:00

Philip Morris International

Quality Compliance Specialist

2020-01-01 00:00:00 - 2021-09-01 00:00:00

Celgene

Quality Operations Specialist

2015-03-01 00:00:00 - 2019-10-01 00:00:00

Smith And Nephew

Qc Specialist (Cell Therapy)

2012-08-01 00:00:00 - 2015-02-01 00:00:00

Takeda

Validation Specialist ( Baxter Sa)

2011-04-01 00:00:00 - 2011-07-01 00:00:00

Gsk

Process Validation Expert

2010-08-01 00:00:00 - 2011-01-01 00:00:00

Genzyme Europe

Coordinator For Process And Cleaning Validation

2006-01-01 00:00:00 - 2010-01-01 00:00:00

Merial

Quality Control Analyst

1998-01-01 00:00:00 - 2000-12-01 00:00:00

Sanofi Pasteur

Senior Research Technician

1996-05-01 00:00:00 - 1997-12-01 00:00:00

Biomerieux

Research Development Technician

1994-08-01 00:00:00 - 1996-04-01 00:00:00

Skills

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Languages

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FAQ About Perrine Lelievre

Perrine Lelievre is located at
Gilly, Gilly, Switzerland

Perrine Lelievre is a > 20 years of expertise for biotechnologies, phamaceutical industry, tobacco industry and medical device sector including early career experience in research and quality control laboratory as technical expert and latter success as quality expert involving in several new biopharmaceutical plant building. Extensive knowledge of biologics ( vaccines, cell therapy, injectable ...), non sterile and sterile product manufacturing, testing and clinical trial studies. I am a strong relationship and trust builder as well as solution oriented. I am willing to continuously strenghten and widen my personal knowledge by learning more from new positions and new processes/responsibilites. Specialties: #GxP #sterileconstraints #continuousimprovment #pragmatism #biopharmaceutical #operationsmanagement #leadership #empower #active communication # stakeholdersoriented #consciousness #openpersonality #assertivity ✦ CORE COMPETENCIES: ✦ Quality Assurance QMS SME for implementation of VEEVA Modules Compliance (Deviation-CAPA-Change Control Handling OOS Investigations Handling for Laboratory) Inspection / Audits Certified Auditor. Internal Audits. Regulatory Inspections (FDA, ANSM,...) QA engineering Review CQV, CSV (IQ, OQ, PQ Protocols, Reports, VMP, Risk Analysis). Transfer validation of the manufacturing process for an injectable (upstream and downstream processes) Development and Validation of methods in QC laboratory (Implementation of analytical validation requirements). Maintain qualified equipment and systems in compliance with policies, guidelines, and procedures Conduct investigations into qualification failures and develop and implement remediation plan. ✦ Quality Control ✦ Immunology testing: ELISA Radioactivity (Chrome51), Flow Cytometer (Activity measurement) Western Blot, SDS Page Direct Agglutination method (agglutinins, hemolysins) Ouchterlony Test ✦ Biochemistry testing: Chromatography (CPG, HPLC, CCM) Spectrophotometry Agarose gel electrophoresis, Capillary Electrophoresis ✦ Virology testing Cells Culture

Perrine Lelievre currently works in the

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Perrine Lelievre has prior
experience in the following industries:
Inlingua Leman | Innopark Suisse | Cytiva | Philip Morris International | Celgene | Smith And Nephew | Takeda | Gsk | Genzyme Europe | Merial | Sanofi Pasteur | Biomerieux

Perrine Lelievre has the following professional experience:
Inlingua Leman | Innopark Suisse | Cytiva | Philip Morris International | Celgene | Smith And Nephew | Takeda | Gsk | Genzyme Europe | Merial | Sanofi Pasteur | Biomerieux