Manufacturing Validation and Calibration documentation specialist (New Capital)

Job Objective

A Manufacturing Validation and Calibration Documentation Specialist is responsible for supporting in creating, maintaining, and controlling technical documentation related to equipment validation, calibration, and compliance activities within new capital manufacturing Site and calibration documentation of Donor centers.

Environment

• Internal: Manufacturing, quality, Engineering, & service divisions
• External: suppliers, Health authorities, Government authorities, and Auditors.

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)
• Assist with department related change controls and their actions.

Academic experience required

• Bachelor's degree in technical or scientific field.
• Knowledge of current Good Manufacturing Practices (cGMP).

Professional Experience Required

• 0-2 years of experience in pharmaceutical field.

Computing Skills

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

Personal Skills

• Good Communication skills

• 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.