Nicolas Bidaud Email & Phone Number

Brisbane, Queensland, Australia

Brisbane, Queensland, Australia

• Facilitation of root cause analysis sessions
• Work groups coordination to ensure corrective actions are implemented
• Deviation reports authoring, review, and approval (Trackwise)
• Deviation reports follow up to ensure that appropriate preventative actions are implemented
• Follow up and monitoring to ensure that effective control measures are in place to prevent deviation recurrence

Brisbane, Queensland, Australia

• Complaint intake, sorting, ranking and investigation
• Complaint management system tendering and commissioning
• Complaint investigation coordination. Different stakeholders (IT, Electronic, Biological, Contract Packer…)
• FDA reporting process set up and maintenance
• Customer service engagement (outsourced customer help line)

Brisbane, Australia

• Management of adverse event reporting and complaints for Cook Medical products
• Electronically process events to determine complaint and reportability status
• Complete electronic submission of applicable Medical Device Reports (MDRs) to the TGA, EU and FDA as required per internal policy & procedures and regulations
• Ensure complaint investigations are adequate, accurate, detailed and timely
• Collaborate with appropriate technical, clinical, field/sales and/or returned product… Show more
• Collaborate with appropriate technical, clinical, field/sales and/or returned product analysis employees to determine reporting eligibility

Brisbane, Australia

• Commissioning of a new manufacturing softgel capsule line
• Selection and auditing of softgel equipment suppliers
• Coordination of softgel validation activities (equipment, premises, process)
• Involvement in TGA audit process (new dosage form manufacturing license)
• Re-qualification of production environment monitoring system
• Commissioning of a new stability chamber

Auckland, New Zealand

• IQOQPQ protocols drafting, execution and review for manufacturing, packing and laboratory equipment
• Coordination of the different qualification stakeholders
• Involvement in the DQ, FAT and SAT process
• Process validation protocols execution and review for solid, oral liquid and softgel capsule
• General utilities qualification (purified water, vacuum, compressed air…)
• High potent manufacturing suite commissioning and qualification

Lyon Area, France

• Engagement with subcontractors
• International suppliers (Australia, Ireland, Spain, Switzerland...)
• Technical support (assistance for new product introduction)
• Formulation, process improvement and streamlining
• Follow up of the stability studies
• Follow up of the manufacturing, packaging schedules and lead timesCoordination of product launches

Melbourne, Australia

• Antigens purification
• Antigens purification on sucrose gradient
• In process and environmental controls
• Handling under safety cabinetAntigens filtration and concentration
• Automated plant handling
• Reagents and buffers dispensing

Melbourne, Australia

• Pellets coating in fluid bed dryer
• Enteric coating on acid sensitive API
• Excipients selection (contacts and negotiations with suppliers)
• Formulation and feasibility studies
• Assessment of the dissolution profile
• Follow up of the stability studies

Lyon Area, France

• Operation of a new microfluidization zone (API micronisation)
• Participation in batch validation
• Automated facility
• Work on ongoing process improvementTwo and three layers tablets compression
• In process control: friability, hardness, weight uniformity, diameter, thickness
• Installation of a tablet metal detector Granulation in fluid bed (microfluidized suspension spraying on lactose support)

Lyon Area, France

• Laboratory development of a liquid form process (parenteral emulsion)
• Microencapsulation of an irritating API
• Compatibility study API / excipients
• Emulsion characterisationParticipation in spray cooling process development
• Cytoxic API Incorporation in a lipidic matrix
• Powder characterisation

Lyon Area, France

• Reformatting dossier in CTD format
• Module 3 (drug product section) of dossier
• Harmonisation between European, Japanese and American presentation Post approval modifications
• Submission of change applications / notifications to European and French regulatory agency
• Change type determination
• Process changes (equipment, critical parameters)

Lyon Area, France

• Pan coater installation and qualification
• Installation Qualification, Operational Qualification, Performance Qualification
• Manufacturing and cleaning procedures drafting Wet granulation in mixer-granulator-dryer
• Equipment fitted with micro waves dryer system and video camera
• In process control: Residual humidity, flowlability, apparent volumeTableting on single station and rotative press
• Technical and clinical batches manufacturing

Lyon Area, France

• Class 100 in a class 1000 environment
• Intermediate product sterile repartition
• Ongoing training for sterile handling
• In process controls: Particule controls (laser counter), Microbiological controls (agar plate, aerobiocollector) Antigens coupling
• Chemical coupling in refrigerated tank
• Critical parameters check (agitation speed, pH, temperature, adding components time-limit) Antigens purification

Lyon Area, France

• Wet granulation in mixer-granulator-dryer
• Routine production of several formulations
• Participate in new product granulation scale up
• CIP system handling Liquids form process (syrups and drinking suspension)
• Operating on three syrup lines (5000, 10 000 and 15 000L)
• Filtration through plaque filters or cartridges

Master, Design And Development Of Product For The Pharmaceutical Industry

Bachelor, Engineering And Quality Of Pharmaceutical Industries

Bachelor, Advanced Diploma Of Science (Pharmaceutical Industry Technician)

Education record