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CQV (Commissioning, Qualification, Verification) Pharmaceutical Consultant

Technical Consultant #2319


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)
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