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Below is a non-exhaustive list of subjects we work on with our partners.
- Definition of the Qualification Strategy and validation master plan
- Drafting documents : Quality and Qualification (Commissioning, Protocol, Studies)
- Drafting / adaptation of protocols CQ/IQ/OQ/PQ
- Execution of Qualification tests and management of non-conformities
- Implementation of CAPA and Change Control
- Supervision and realization of FAT/SAT
- Drafting reports
- Development of regulatory strategies
- Drafting reports, submission and variations to health authorities
- Validation of packaging items
- Publishing
- Drafting of technical files in compliance with regulations 2017/745 and 746
- Performing Change Control and updating internal procedures
- Study Supervision
- Definition of the need and framing of the project
- Drafting specifications
- Planning
- Consultation and choice of suppliers
- Management of costs, quality, deadlines
- Reception of equipment and monitoring of work
- Preparation and support for audits of notified bodies
- Implementation of Quality Management Systems
- Drafting of CAPA, SOP, CC
- Audits and supplier panel rationalization
- Review, release, and recall of batches
CRA
- Pre-selection, initiation, and closure visits to investigator sites
- Control of the application of procedures and regulations regarding Monitoring and Safety
- Drafting reports and archiving documentation
Local and global clinical project manager
- Design and implementation of clinical trials
- Management of schedules, budgets, and resources
- CRO oversight
- Supply management and shortages anticipation
- Planning (supply, production flow)
- Inventory management
- Sales Forecast
- Logistics
- Study, selection, and monitoring of subcontractors (CMO)
- Transition management
- PMO/Strategic program management
Studies
- Definition and sizing of installations
- Creation of P&IDs
- Writing technical specifications, functional analyses analysis, and operating manuals
- Participation in the choice of the technical solution
- Managing interactions with suppliers
On-site :
- Production monitoring
- Improvement of manufacturing processes
- Installations compliance
- Risk analysis
- Writing validation plans, traceability matrix and validation file reporting protocols
- Organization of tests, monitoring of nonconformities
- Support for periodicals reviews
- Compliance (Data Integrity, 21 CFR Part 11, GAMP 5)
- Samples management (Physical and documentary)
- Analyses (Microbiology, Physicochemical, etc.) and stability studies according to ICH and USP
- Transfer and validation of analytical methods (HPLC, UPLC, GC, etc.)
- Monitoring of deviations and management of failures
- Maintaining conformity, quality, and safety of premises and equipment
- Establishing critical project path / planning
- Definition of milestones
- Tracking milestones, progress, and budget
- Communicating about the schedule and the critical path with the project team
- Deviation management
- Reporting
- Resolution of problems impacting compliance with the schedule (speeding up / slowing down)
- Choice and implementation of project monitoring tools
- Communication with various departments regarding the project
- Tracking contracts, orders and deliverables
- Creation of stakeholders mapping
- Understanding Process Mapping
- Communication plan development :
- Internal and external
- Online learning and digital training
- Intranet
- Inclusion of the topic in events planned by other speakers
- Co-construction of change management with the stakeholders
- Development of a training program with stakeholders
- Identifying urgent short-term needs
As part of a project on a pharmaceutical site, the company is acting as project manager for the implementation of a new process and the revamping of all buildings linked to this project (STEP, Laboratory, Production, Maintenance….):
- Production schedule management, identification of bottlenecks
- Cost management of the different phases of the project, identification of critical points
- Organization and follow-up of equipment receptions (mechanics, IQ/OQ/PQ)
- Participation in technical choices
- Organization of steering and reporting ( KPIs) to the main project manager and participation to the steering committee
- Participation in project meetings with various stakeholders (external engineering, HSE, Quality, Project Manager, Process and EIA study managers).
- Ensuring the application of processes, standards, and requirements at all stages of the project.
As part of the reorganization and creation of a Packaging Life Cycle Management expertise centre , we created and managed it by :
- Creation and management of an expertise center on Packaging Life Cycle Management
- The Definition of a RoadMap
- The mapping of resources, processes, and tools
- The definition of objectives and their implementation
- The Implementation of new tools
- Setting up service assessments
- Implementation of assessments on the service
- The Change Management
- The Team Management
