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Quentin Morjon

- Process and Analytical Technology Transfer management - QA representative for Process Development department - QA support and... | France

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Quentin Morjon’s Location France

Quentin Morjon’s Expertise - Process and Analytical Technology Transfer management - QA representative for Process Development department - QA support and coordination on process validation stage I Process Design 1. Review and approbation of CQA, CPP, toxicological, extractables & Leachables and CMA assessments 2. Review and approbation of Small Scale Qualification studies, CPP-CQA definition and PAR confirmation studies 3. Review and approbation of media/buffers and intermediates stability and homogeneity risk assessment 4. Definition, review and approbation of preliminary Process Control Strategy - Supervizion of process validation stage II PPQ 1. Review and approbation of PPQ protocol 2. Deviations and OOS management 3. Review and approbation of stability, homogeneity, blank run, resin lifetime, clean hold times and shipment studies - Life Cycle Management of validated process 1. Redaction of CPV protocol 2. Coordination of PCS updates 3. Coordination of data collection and CPV reports redaction 4. Batch record review and release 5. Annual Product Quality review redaction - Preparation and participation in audits and inspections - Validation Master Plans & Reports redaction (Site and projects) - SOPs redaction: Quality by Design, Process Validation, PCS establishment and management, CPV management - QA support on analytical validation and transfer on various method (HPLC/UPLC, OD, cIEF, qPCR, ELISA, Bioburden, Endotoxins) - QA support on stability studies: IPC, DS & DP - Equipment Qualification: redaction, review and approbation of IQ/OQ/PQ risk analisys, protocols, raw data and reports. - Redaction and Execution of IQ/OQ protocols and tests on tanks, pipes, HVAC, utilities and clean rooms - Redaction of risk assessment on environmental/microbiological controls - Redaction of risk assessment, IQ/OQ protocols and tests on automatism - Supplier’s audits - Scheduled and preparation of Media Fill Test - Definition and follow up of CAPA plans (from customer audits and French health authorities inspection) - Elaboration and follow up of metrological and maintenance plan - Deviation assessment and investigations (utilities and qualification activities related). - Redaction of risk assessment (FMEA) on Steam generator and sterilization process - Redaction and Execution of DQ/IQ/OQ protocols and tests on highly purified water system, steam generator, sterilization process - Redaction and execution of IQ/OQ/PQ protocols and tests on utilities: pressurized air, nitrogen - Suppliers management - Redaction of equipment SOPs and operators training. - Monitoring of quality indicators (inter-lab assays, on going deviations and CAPAs) - Implementation of a new Quality Manual - Equipment qualification - Handling and investigation of technical complaints - Training of a production team to an on-line quality system (documentation and deviations).

Quentin Morjon’s Current Industry Merck Group

Quentin Morjon’s Prior Industry
Eurofins | SEPPIC | Merck Group

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Work Experience

Merck Group

Validation Expert

Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

SEPPIC

Quality Assurance Engineer

Fri Aug 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Dec 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)

SEPPIC

QA trainee

Sat Feb 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Aug 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)

Eurofins

Quality Trainee

Mon Apr 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Sep 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)

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Languages

Quentin Morjon Email Addresses

[email protected] Email

Quentin Morjon Phone Number

No phone number available. Phone number

FAQ About Quentin Morjon

Quentin Morjon is located at
France

Quentin Morjon is a
- Process and Analytical Technology Transfer management - QA representative for Process Development department - QA support and coordination on process validation stage I Process Design 1. Review and approbation of CQA, CPP, toxicological, extractables & Leachables and CMA assessments 2. Review and approbation of Small Scale Qualification studies, CPP-CQA definition and PAR confirmation studies 3. Review and approbation of media/buffers and intermediates stability and homogeneity risk assessment 4. Definition, review and approbation of preliminary Process Control Strategy - Supervizion of process validation stage II PPQ 1. Review and approbation of PPQ protocol 2. Deviations and OOS management 3. Review and approbation of stability, homogeneity, blank run, resin lifetime, clean hold times and shipment studies - Life Cycle Management of validated process 1. Redaction of CPV protocol 2. Coordination of PCS updates 3. Coordination of data collection and CPV reports redaction 4. Batch record review and release 5. Annual Product Quality review redaction - Preparation and participation in audits and inspections - Validation Master Plans & Reports redaction (Site and projects) - SOPs redaction: Quality by Design, Process Validation, PCS establishment and management, CPV management - QA support on analytical validation and transfer on various method (HPLC/UPLC, OD, cIEF, qPCR, ELISA, Bioburden, Endotoxins) - QA support on stability studies: IPC, DS & DP - Equipment Qualification: redaction, review and approbation of IQ/OQ/PQ risk analisys, protocols, raw data and reports. - Redaction and Execution of IQ/OQ protocols and tests on tanks, pipes, HVAC, utilities and clean rooms - Redaction of risk assessment on environmental/microbiological controls - Redaction of risk assessment, IQ/OQ protocols and tests on automatism - Supplier’s audits - Scheduled and preparation of Media Fill Test - Definition and follow up of CAPA plans (from customer audits and French health authorities inspection) - Elaboration and follow up of metrological and maintenance plan - Deviation assessment and investigations (utilities and qualification activities related). - Redaction of risk assessment (FMEA) on Steam generator and sterilization process - Redaction and Execution of DQ/IQ/OQ protocols and tests on highly purified water system, steam generator, sterilization process - Redaction and execution of IQ/OQ/PQ protocols and tests on utilities: pressurized air, nitrogen - Suppliers management - Redaction of equipment SOPs and operators training. - Monitoring of quality indicators (inter-lab assays, on going deviations and CAPAs) - Implementation of a new Quality Manual - Equipment qualification - Handling and investigation of technical complaints - Training of a production team to an on-line quality system (documentation and deviations). Merck Group

Quentin Morjon currently works in the
Merck Group

Quentin Morjon specializes in
- Process and Analytical Technology Transfer management - QA representative for Process Development department - QA support and coordination on process validation stage I Process Design 1. Review and approbation of CQA, CPP, toxicological, extractables & Leachables and CMA assessments 2. Review and approbation of Small Scale Qualification studies, CPP-CQA definition and PAR confirmation studies 3. Review and approbation of media/buffers and intermediates stability and homogeneity risk assessment 4. Definition, review and approbation of preliminary Process Control Strategy - Supervizion of process validation stage II PPQ 1. Review and approbation of PPQ protocol 2. Deviations and OOS management 3. Review and approbation of stability, homogeneity, blank run, resin lifetime, clean hold times and shipment studies - Life Cycle Management of validated process 1. Redaction of CPV protocol 2. Coordination of PCS updates 3. Coordination of data collection and CPV reports redaction 4. Batch record review and release 5. Annual Product Quality review redaction - Preparation and participation in audits and inspections - Validation Master Plans & Reports redaction (Site and projects) - SOPs redaction: Quality by Design, Process Validation, PCS establishment and management, CPV management - QA support on analytical validation and transfer on various method (HPLC/UPLC, OD, cIEF, qPCR, ELISA, Bioburden, Endotoxins) - QA support on stability studies: IPC, DS & DP - Equipment Qualification: redaction, review and approbation of IQ/OQ/PQ risk analisys, protocols, raw data and reports. - Redaction and Execution of IQ/OQ protocols and tests on tanks, pipes, HVAC, utilities and clean rooms - Redaction of risk assessment on environmental/microbiological controls - Redaction of risk assessment, IQ/OQ protocols and tests on automatism - Supplier’s audits - Scheduled and preparation of Media Fill Test - Definition and follow up of CAPA plans (from customer audits and French health authorities inspection) - Elaboration and follow up of metrological and maintenance plan - Deviation assessment and investigations (utilities and qualification activities related). - Redaction of risk assessment (FMEA) on Steam generator and sterilization process - Redaction and Execution of DQ/IQ/OQ protocols and tests on highly purified water system, steam generator, sterilization process - Redaction and execution of IQ/OQ/PQ protocols and tests on utilities: pressurized air, nitrogen - Suppliers management - Redaction of equipment SOPs and operators training. - Monitoring of quality indicators (inter-lab assays, on going deviations and CAPAs) - Implementation of a new Quality Manual - Equipment qualification - Handling and investigation of technical complaints - Training of a production team to an on-line quality system (documentation and deviations).