Operations Technical Specialist

• 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.