Quality management system (QMS)
Build, update, and monitor QMS
- Analyze current process
- Optimize and improve lean processes
- Draft standard operating procedures (SOPs), standard working instructions, templates, records, and quality manual
- Draft quality KPIs and quality index
- Write annual quality system review, and anticipate or identify gaps
Process and product quality risk analysis
Product quality review and trends analysis (stability, capability)
Collect data, build trends, write complete product quality reviews (PQRs) or coordinate or liaise with suppliers and assess their PQRs, and identify potential risks and corrective actions and preventive actions (CAPAs) for manufacturers or—for the French market, exploitants (wholesale distributors authorized and inspected by the French competent authority).
Deviations/CAPAs and complaints management
Collect data, provide expertise on processes, and deliver assessments.
Change control management
Coordinate change impact assessment, define steps and actions and planning and due dates, coordinates implementation of agreed actions, conduct final assessment, and complete the change control process.
Quality technical agreements
Perform maintenance, implement quality writing, and update contracts.
- Support quality culture change and staff training.
- Provide expertise in the forms of a qualified person, a responsible pharmacist, and a quality assurance officer or manager.