Validation Section Head GlaxoSmithKline

You will lead a team that plans, executes and maintains validation activities at our Egypt site. You will work with Quality, Production, Technical Services and Regulatory teams to ensure processes, equipment and systems meet compliance and quality standards. We value people who are practical, curious and focused on safety and continuous improvement. This role offers clear growth, visible impact on product quality and the chance to apply science, technology and talent to get ahead of disease together.

Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Lead the validation section and own the Site Validation Master Plan and related priorities.
• Design, review and approve process, cleaning, bulk holding time, air and water system validation protocols and reports.
• Coordinate different thermal mapping activities (initial qualification and thermal mapping review) -Prepare required validation life cycle documents (not limited to: DR, RTM, CDA, IQ, OQ, PQ, Validation reviews, PQ reports and VSRs) for different activities for process equipement and utilities upgrade in accordance to validation lifecycle and CSV requirements.
• Handling calibration program for Lab instruments.
• Maintain validation lifecycle records and keep systems inspection ready through periodic reviews and self-inspections.
• Support investigations, change controls and CAPAs linked to validation activities and lead root cause analysis with cross-functional teams.
• Coach and develop team members, share best practice, and drive continuous improvement in validation methods and documentation.