Project Management

We manage projects for the introduction of new products in chemical-pharmaceutical companies.

Namely:

• We supervise all pre-validation and validation activities related to manufacturing and packaging processes
• We handle deviations, CAPAs and requests for change in related business systems.
• We draw up and update Standard Operating Procedures and Master Batch Records for manufacturing and packaging in a GMP perspective (Good Manufacturing Practice).

We manage E2E technology transfer projects for the manufacturing and packaging sectors.

Namely:

• We oversee the assessment of a site for its suitability for a specific project and evaluate the associated risks (Due Diligence).
• We provide technical support for the entire transfer during the production of development, optimisation and validation batches
• We troubleshoot and support the QC and production departments in dealing with deviations and investigations
• We validate documentation

We manage LCM (Lifecycle Management) projects related to consumer and OTC products.

Namely:

• We select new manufacturing sites
• We perform feasibility and financial analyses
• We develop budgets and business cases
• We manage cross-functional teams
• We monitor project performance (lead times, costs, quality, risks, communications)

We manage Packaging reengineering projects

Namely:

• We support the Engineering in identifying new packaging that meets the needs of the market
• We co-ordinate and support the R&D department for the development of “user friendly” packaging with a different Child Resistant grading
• We co-ordinate the activities of Engineering, Technical Operations, Production, Planning and Quality departments for machine qualification, installation of new packaging lines, validation of new product packaging
• We oversee cleaning activities and issue documentation in compliance with GMPs and launch schedules
• We manage activities related to distribution testing
• Shipping study

We manage E2E Life Cycle Management (LCM) projects within the Value Chain Management PMO project portfolio.

Namely:

• Supply Chain Projects, with Technology Transfer and Product Launches where applicable
• Optimisation of the project portfolio (delisting, divestment, simplification)