CQV (Commissioning, Qualification, Verification) Pharmaceutical Consultant

Expertise

• Pharmaceutical standards regulations: BPF, BPL, GMP, Europ%uFFFFe Pharmacop%uFFFF and FDA 21CFR part.11.
• Quality assurance and the standards regulations requirements for the pharmaceutical industry.

Methodology

• Risk Analysis (AMDEC, HACCP)
• Six Sigma

Technical Execution

• Pharmaceutical quality assurance and the standards regulations requirements.
• Design, quality, commissioning and qualification documentation of pharmaceutical processes.
• FAT, (Factory Acceptance Testing),SAT, (Site Acceptance Testing) commissioning, (re)qualification and validation tests.
• Aseptic processing: Filling line (washer, tunnel, filling machine, isolators, CIP (Clean-In-Place and SIP (Sterilization-In-Place, magazine handling unit, Tank TCM-Temperature control module), isolator conventional and non- conventional, sterilizers, lyophilizer, SIP and CIP systems.
• Equipment: Packaging equipment including bar code vision systems and labelers,
• Laboratory systems: stability chambers, cold rooms, particle counters, filter integrity testers, microbial identification units, heat sealer, precision weighing, LIMS and HPLC.
• Utilities: WFI and purified water systems, HVAC, compressed air and inert gases, clean steam, nitrogen, and DCM networks.

Pharmaceutical Equipment

• Washer
• Tunnel
• Filling machine
• Isolators
• Magazine handling Unit
• Labeling machine
• Heat sealer
• Autoclave
• Containers for isolators, RTP and Hoover
• Lyophilizer
• HVAC equipment
• Heat exchanger
• Tanks

Experience

Undisclosed Company, Consultant-Qualification Engineer, 2014 - Present

Project-CGV3. (Global Project, English Documentation). Qualification: Filling line; washer, tunnel, filling machine, isolator and CIP/SIP, magazine handling unit, tank, temperature control module.

• Installation Qualification Leader: Managing a team performing numerous functions.
• Documentation of the IQ protocol.
• Static test execution.
• Review and presentation of the raw data.
• Documentation of the SAT report.
• Corrections of the discrepancies.
• Operational qualifications tests executions for the magazine handling unit.
• Operational qualification tests of the line (alarms tests, functional sequences, HSE tests, performances tests.

Site Acceptance Tests - SAT

• Documentation of the SAT protocol.
• Static and dynamic test execution.
• Review and presentation of the raw data.
• Documentation of the SAT report.

Factory Acceptance Tests (Bosch Plant in Germany) SAT

• Documentation of the FAT protocol.
• Static and dynamic test execution.
• Review and presentation of the raw data.
• Documentation of the FAT report.

Design

• Update of the design documentation (user requirements UR, software requirements user SWR, commissioning and qualification work plan CQWP, Description of the system DSP, Classification CLA).

Washer (Design)

• Review of the P&ID.
• Update of the design documentation (UR, SWR, CQWP).

Sterile Container

• Documentation of the FAT protocol.
• Static and dynamic test execution.
• Modification of the design of the container after check in site.
• Review and presentation of the raw data.
• Documentation of the FAT report.

Ipsen Pharmaceutical, Signes, France, Qualification and Validation, 2013

Liophilizer

• Validation of a new Liophilizer recipe.
• Modification of the Liophilizer pressure probes.
• Modification of the sequencing of the Liophilizer valves.
• Documentation of the IQ an OQ protocols.
• Planning and testing.
• Documentation of the IQ and OQ reports.

Labeler Marchesini - SAT/QI/QO

• Documentation of the IQ an OQ Protocols.
• Planning and testing (SAT, IQ, OQ).
• Documentation of the IQ and OQ reports.

Heater Sealer

• Set-up (Determination of the temperature coefficient).
• Documentation of the IQ an OQ Protocols.
• Planning and testing (SAT, IQ, OQ).
• Documentation of the IQ and OQ reports.

Oven

• Documentation of the IQ an OQ Protocols.
• Planning and testing (SAT, IQ, OQ).
• Documentation of the IQ and OQ reports.

Network Utilities (Nitrogen, Alcohol and DCM)

• Documentation of the IQ an OQ Protocols.
• Planning and testing (SAT, IQ, OQ).
• Documentation of the IQ and OQ reports.

Sanofi, Le Trait, France, Consultant - Qualification Engineer, 2013

Isolator not conventional (RABS configuration)

• Aeraulic qualification (smoke test).

Isolator Conventional

• Aeraulic qualification (smoke test).
• Particulate mapping.

Geurbet, Aulnay Sous Bois, France, Consultant Engineer, 2012 - 2013

Project: CD1-Qualification and Validation - HVAC and Local

• Planning and testing, SAT, IQ, OQ.
• Documentation of the IQ and OQ reports.

Research and Development Technician, 2009

Autoclave Fedegari

• Documentation of the Qualification Performance Protocol (PQP).
• Development of a new recipe (new load).

Depyrogenation Oven Fedegari

• Documentation of the PQP.
• Determination of the worst case load.

Washing Machine HAMO

• Documentation of the Operational Qualification Protocol.
• Development of a specific test 'effectiveness of chemical removal.'
• Validation of a new analysys method for the 'effectiveness of chemical removal test.'

Network Azote Balances (Mettler) and Heat exchanger

• Update of the OQP.
• Planning and testing.
• Documentation of the report.

Balances (Mettler)

• Update of the OQP.
• Planning and testing.
• Documentation of the OQ report.

Heat Exchanger

• Documentation of the IQ and OQ Protocol.
• Planning and testing.

Industrial Development

• Support for the Technical and clinical batch production.
• Updates of the SOP.
• Risks analisys.

Catalent, Beinheim, France, Consultant, Qualification Engineer, 2012

Project: Siemens (Network Chilled Water Utilities Automates) Qualification and Validation

• Performed chilled water utilities automates through IFIX 5.0.
• Documentation of the FAT and SAT protocols.
• Planning and FAT (Actemium at Strasbourg) and SAT testing.
• Documentation of the FAT and SAT report.

LFB,Les Ulis, France, Consultant, Qualification Engineer, 2011 - 2012

Project: ADEAE-Qualification and Validation - Tanks (14 units)

• Documentation of the SAT, IQ an OQ protocols.
• Planning and testing (SAT, IQ, OQ).
• Documentation of the IQ and OQ reports.

Autoclave

• Validation of a new autoclave load.
• Documentation of the OQ Protocol.
• Planning and testing.
• Documentation of the OQ report.

Stallergene, Antony, France, Research and Development Technician, 2011

VSI (Excel files validation)

• Planning and testing.
• Update of the Excel files.
• Documentation of the IQ and OQ reports.

Le Moulin De Corberl, Biologist and Microbiologist Technician, 2009

• Quality control (Dosage, spectophotometry).
• Reception, samples management.

Sonofi Winthrop Industrie, Maison Alfort, France, Biologist - Microbiologist Technician, 2007 - 2008

• HVAC Validation (aseptic filling.)
• Quality control (weighing, penicillin analysis, bacteria enumeration, microbiological sampling).
• Documentation of the SOP.

CIS-BIO International, Cea Saclay, France, Biologist Technician, 2007

Research and Development Technician

• Quality control, weighing, microbiological sampling, filters WIT.

Inserm, Paris France, Biologist and Microbiologist Technician, 2005 - 2006

• Study on a Human enzyme (enzyme induction, ELISA method, bacteria enumeration.

Honors & Publications

Languages

• French: First language
• English: Good proficient in English (spoken and written)
• Thai: Basic speaking skills (continued education at RTL school and AUA language center at Bangkok)
• Spanish: Proficient

Education

• B.S. Biochemistry (ESTBA Technical College, Paris, France)
• B.S. Laboratory Science (St LEON College, Corbeil Essonne, Lie, France)