Pharmaceuticals & Chemicals
Due to increased pressure on cost from clients and control of health expenses from governments, Pharma and Chemical industries are facing new challenges:
- The homogenization of the production practices forces companies to re-configure Supply Chain integrating the contribution of new technologies,
- The movements of mergers & acquisitions industry. Giants appear such as Pfizer Inc, GSK or Sanofi-Aventis.
- Globalization leading to the emergence of new actors in the low-cost countries and the evolution of the balance of power between laboratories and actors of the retail chain.
- Increasing regulation (FDA & EMEA)
- Increasing public and regulatory attention towards global risk management
Our recent assignments in Pharmaceuticals & Chemicals
- Global Process Change Management for a major pharmaceutical company during the H1N1 Pandemic Flu in order to coordinate process actors and activities between different departments in different countries (Belgium, France, Germany, US, Canada): quality assurance, quality control, logistics.
- Production sites validation activities coordination and follow-up in collaboration with technical services and product transfer experts.
- Follow-up of international sub-contractors for production activities and management of quality aspects (deviation and CAPA management, release of commercial batches, quality system transfer...)
- Management and coordination of the audit of our clients production site by the Mexican authorities (from the preparation to the answer regarding highlighted issues)
- Management of a continuous improvement project using lean and/or 6-sigma methodologies at different levels of a formulation business unit (5S, DMAIC, VSM, Pareto...)
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