Operations Technical Specialist at GRIFOLS, S.A.

Cairo, Cairo, Egypt -

Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

0.0

Posted On

28 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Deviation Management, CAPA, Change Control, Quality Management Systems, cGMP, Root Cause Analysis, Operational Excellence, SAP-QM, TrackWise, Veeva, Data Analysis, Process Improvement, Compliance, Documentation Practices, Stakeholder Management, KPI Tracking

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

Manage deviation and CAPA systems to identify root causes and implement corrective actions to improve operational quality. Oversee operational change control processes and lead continuous improvement initiatives to enhance efficiency and compliance.