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
Internal: 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.
External: NA.
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 biotechnology, Pharmaceutical, 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 or more of related experience in GMP Quality Systems in a 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).
Grifols Egypt for plasma derivatives is a joint-venture (JV) company between the Egyptian Government, through the National Service Projects Organization (NSPO) and Grifols, the global leader in plasma medicines with more than 110 years of contribution to improving the health and well-being of people.
This joint venture is the first of its kind in the plasma industry and the first-ever Egyptian source member of the Plasma Protein Therapeutics Association (PPTA). GEPD is a groundbreaking global public-private alliance that will benefit the entire region.
GEPD is committed to developing the plasma medicines market and achieving self-sufficiency in these critical therapies, which is crucial for the Egyptian healthcare system.
We are combining the expertise of both shareholders to build and operate 20 plasma donation centers throughout Egypt, along with manufacturing facilities including fractionation, purification, and fill-and-finish plants with a processing capacity of up to 1 million liters of plasma annually that can double in the future.
The new manufacturing facility will include a plasma warehouse and a testing laboratory. It will occupy 105,000 square meters strategically located in the administrative capital’s medical city, adjoining various healthcare institutions.
