Manufacturing Validation and Calibration Documentation Specialist

Grifols Egypt for Plasma Derivatives

Key responsibility 

• Handle and Maintain validation documentation, including:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation protocols and reports
• Handle and Maintain calibration records for manufacturing and laboratory equipment
• Ensure documentation complies with:
• GMP (Good Manufacturing Practices)
• ISO standards
• FDA or other regulatory requirements
• Coordinate some activities with internal stakeholders such as engineering, quality assurance, manufacturing, and maintenance teams. As well as external Vendors and service providers.
• Review technical changes and update controlled documents
• Support audits and inspections by providing accurate records
• Track calibration schedules and validation status
• Track pending documents on DCM.
• Assist with department related deviation investigations and corrective actions (CAPA)/li>
• Assist with department related change controls and their actions.

Computing Skills /strong>

• Basic knowledge of Microsoft office and software systems (SAP)/li>
• Familiarity in using maintenance management software systems (SAP PM or similar).
• Familiarity in using BMS Software program

Personal Skills/strong>

• Good Communication skills/li>

• Strong technical writing and document control abilities.
• Attention to detail and organizational skills.
• Good organizational and time management skills.

• Ability to work independently and as part of a team.

• Familiarity with calibration and validation systems.
• Familiarity with GMP and quality requirements.