- Follow the approved deviation management and CAPA system, involving appropriate stakeholders for investigation and closure.
- Proactively identify root causes of deviations and implement corrective and preventive actions to reduce their occurrence.
- Monitor and analyze deviation trends to identify areas for improvement and implement strategies to minimize the number and impact of deviations.
- Work closely with cross-functional teams to ensure timely closure of deviations, reducing the overall time taken for resolution.
- Coordinate and oversee the implementation of operational change control processes.
- Work closely with cross-functional teams to ensure changes are documented, reviewed, and executed efficiently.
- Identify and lead continuous improvement initiatives in operational processes to enhance efficiency and quality.
- Maintain and optimize systems used for tracking and managing deviations and change controls.
- Develop and implement standardized documentation practices to ensure consistency and compliance across all operational processes.
- Serve as a key liaison between operations and other departments regarding process management.
- Provide training and guidance to employees on operational compliance and system updates.
- Compile all information related to the different processes referred to key process indicators established for plasma supply chain areas.
Academic experience required
- Bachelor's degree in Engineering, Health-related Sciences, or a related field.
- Knowledge of Quality Management Systems.
- Knowledge of current Good Manufacturing Practices (cGMP)
- Minimum of 2 years of related experience in GMP Quality Systems.
- Minimum of 5 years of professional experience in the pharmaceutical, biotech, or regulated manufacturing industries.
- Experience with GMP regulations, deviation handling, and change control processes.
- Familiarity with CAPA investigations and operational excellence methodologies.
- Knowledge of Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
- Experience with electronic quality management systems such as SAP-QM, TrackWise, Veeva, or similar platforms.
- Ability to analyze data and generate reports using database management tools.
