Operations Technical Specialist
Grifols Egypt for Plasma Derivatives
Employer Active
Posted 2 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
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.
Other duties as assigned
Desired Candidate Profile
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).
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.
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.
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.
Proficiency in English and Arabic (professional-level reading, writing, and communication
required).
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Quality
- Testing
- QA
- QC
- Inspector
Keywords
- Operations Technical Specialist
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Grifols Egypt for Plasma Derivatives
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.
https://www.careers-page.com/grifols-egypt-for-plasma-derivatives/job/63VR56WW