Job objective :
Responsible for ensuring that operational systems and processes comply with local and international regulations, as well as internal company standards. The role involves managing and improving operational processes related to change control, deviation management, and continuous improvement within the donor center and/or plasma logistic center. This position ensures compliance with industry regulations and company policies while enhancing operational efficiency through effective system oversight and process optimization.
Environment :
Collaborates with operations, production, validation, and quality teams to ensure seamless execution of change control and deviation documentation.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Key responsibility :
Deviation and CAPA Management:
- 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.
Change Control Management:
- 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.
Process Improvements:
- 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.
Documentation Standardization:
- Develop and implement standardized documentation practices to ensure consistency and compliance across all operational processes.
Collaboration and Training:
- 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.
Key Process Indicators:
- Compile all information related to the different processes referred to key process indicators established for plasma supply chain areas.
Other duties as assigned.
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).
Professional experience required
- 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.
Computing skills
- 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.
Personal skills
- Strong problem-solving and analytical skills.
- Excellent organizational and time management abilities.
- Effective communication and collaboration with cross-functional teams.
- Ability to work independently and manage multiple tasks in a fast-paced environment.
- Strong integrity and commitment to quality and compliance.
- Excellent interviewing, listening, and observation skills in order to obtain the information needed to fully grasp and document a process.
- Demonstrated ability to organize work and keep comprehensive substantiating records.
Languages
Proficiency in English and Arabic (professional-level reading, writing, and communication required).
