Manufacturing sites

Towards predictive and individualised medicine

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Our positioning enables us to work on the overall life cycle of a health product.

Vakgebieden

Quality Assurance (Release of Lots, Change Control, CAPA Management, etc.)
Quality Control (Raw Materials, Micro-biology, product stability, etc.)
Qualification of equipment and installations (IQ/OQ/PQ)
Process Validation / Cleaning Validation (CIP, SIP) / Validation IS
Regulatory affairs (maintaining commercial release authorisation, drafting of technical documents, etc.)

Qualification of formulation/production equipment and validation of a cleaning process: drafting of IQ/OQ/PQ protocols, coordination of tests and drafting of qualification reports
Drafting of validation master plans, supervision of cleaning runs, sampling actions
Quality Assurance on sterile filling site: change control, release of lots, deviations, non-compliances, complaints, preventive and curative action (CAPA / risk analysis)
Environmental supervision on a business park: coordination of sampling campaigns, proof reading of site qualification protocols, drafting of a site supervision strategy
Regulatory affairs: drafting of the module 3 the recording of monoclonal antibodies, management of the GSS and drafting of external change controls

Engineering / preliminary outline – APS / final design – APD/ Detail studies (Process, Electricity, Mechanical engineering, Civil Engineering, Instrumentation, Pipe systems, etc.)
Supervision / Installation on site
FAT/SAT, Commissioning
Supervision of technical shutdowns / Maintenance / HSE
Project management
Transfer / industrial conversion

New works project management on restoring the compliance of in-situ cleaning stations following FDA remarks. Supervision of project from the design phase up to completion, supervision of sub-contractors, FAT, SAT and commissioning of the new installation
Supervision of a production line transfer site, from site A to site B. Supervision of the line dismantling site, supervision of equipment transit logistics and supervision of the reinstallation site and of the commissioning of the installations
Supervision of technical shutdown works: planning of works, reception of sub-contractors, leading work site meetings, maintaining work site safety
Serialisation and aggregation project management for Brazil and China: drafting of specifications for marking and vision systems, call for tenders from suppliers, FAT/ SAT, supervision of installation

Continuous Improvement and Lean Manufacturing (5S / Kaizen / 6 Sigma / TPM continuous)
Project Management
Planning
Cost Control / Contract Management
Risk Management

Operational deployment of the Lean on a production site: supervision of 5S site, setting up of visual management, updating of performance indicators, running of Lean workshops, operator training, etc.
Planning of industrial building construction and plant qualification processes (IQ, OQ, PQ, VP) using the MS Project software package
Production engineering project management (cost, quality, delivery dates) for a new self-injector not approved by the FDA
Cost Control on two CAPEX investment projects for the renovation and extension of an industrial building (setting up of a cost structure, management of change orders, setting up and supervision of a financial performance supervision plan, etc.)

Purchasing of products/equipment (raw materials, packaging, industrial equipment)
Purchasing of services (works contract, clinical studies, transport, etc.)
Management of internal and external flows
Stock management (Kanban, etc.)
Development of Primary and Secondary packaging

Purchasing of equipment and works contracts for the construction of a new industrial site: sourcing, preliminary qualification, short list, issue of calls for tender, technical and commercial clarifications, negotiation and contractualisation
OPEX purchasing (production and secondary packaging) and definition of a new provisioning strategy on a medical systems production site
Packaging development and production engineering: development of packaging for the launching of new products, product transfer, packaging technical unification and production engineering
Optimisation of internal flows on an industrial site between the raw materials storage building and the production building: analysis and mapping of the flows, optimisation of logistics procedures and safety for raw materials transport