Comprehensive Product Management: Oversee the entire commercial lifecycle of the product, from its transfer by development to the present date, acting as the Single Point of Contact (SPOC).
Risk Analysis and Quality Control: Create, update, and monitor the product-specific Quality Risk Analysis (QRA) and ensure compliance with quality standards.
Data Monitoring and Analysis: Evaluate critical and key variables through statistical analysis, track data trends, and review the Annual Product Quality Review (APQR) to make informed decisions regarding control status.
Inspection Readiness: Ensure all aspects related to the product process are prepared for audits and regulatory inspections.
Performance Monitoring and Improvement: Identify trends, detect issues, and lead the implementation of corrective and preventive actions (CAPAs) to enhance products.
Deviation Management and Improvement Projects: Investigate process deviations, lead optimization projects, and engage cross-functional teams in improvement initiatives.
In-Process Controls (IPC) Monitoring: Ensure the tracking of critical parameters in laboratories and guarantee that data is visible and communicated at the plant level.
Technical Change Assessment: Analyze the impact of process modifications, determine their feasibility, and manage the quotations associated with these changes.
Process and Product Validation: Ensure continuous validation status, alignment with the APQR, and implementation of control strategies based on Critical Quality Attributes (CQA), Critical Process Parameters (CPP), and Critical Material Attributes (CMA).
Product Launch and Transfer: Facilitate product transfers by ensuring technical documentation and providing necessary support to the receiving plant.
Manufacturing Optimization and Excellence: Lead improvement projects to enhance the robustness and sustainability of pharmaceutical processes in collaboration with Operational Excellence (OPEX).
您的个人资料
University degree in a scientific field or related, or a higher vocational training degree in a scientific field with previous experience in a similar position.
High level of English.
Experience in a similar technical position and in the pharmaceutical sector.
Knowledge of data management and application of statistical techniques.