Operation Technical Specialist -...
Nasr City, Cairo
Operation Technical Specialist - Nasr City
Nasr City, Cairoposted 1 month ago21Applicants for1 open position
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Job Details
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Job Description
- 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.
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.
Job Requirements
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).