Validation Manager At GSK Egypt
Job Purpose:
Manage and ensure the implementation of Pharmaceutical validation activities in regards to Process validation, Bulk Holding Time validation, Cleaning validation, Analytical Equipment Validation, Air system & Water System qualifications.
Manage & ensure the implementation of Media Fill runs & issuance of Media Fill Protocols & Reports as per the mandated requirements and policies.
Manage and ensure Executing the Validation Lifecycle for all new and existing GxP systems, ITMS & Computer system Validation systems as per mandated requirements and policies.
Maintain the validation status for all above mentioned systems through the Validation lifecycle management, validation review plans and self inspections.
Provides leadership within Quality Processes focusing on building and strengthening deployment of PPR, CPV systems.
Key Responsibilities:
Maintain all validation , PPR & CPV activities in an inspection ready state for any internal and external audits to ensure successful inspection and acting as the site SME for any Validation related topic.
Accountable for the maintenance of the (Equipment Qualification, Computer system validation, lab equipment Qualification , Process Validation, Bulk Holding Time and Cleaning validation plans) to be updated and aligned with the Regulatory updates requirements.
Ensure effective implementation of Computer system validation (CSV) lifecycle in Site.
Reviews & approves the validation documents for the validation life cycle example: (SVMP, VMPs, VPs, VSRs, Equipment and Analytical Qualification documents and Department’s SOPs).
Review & approve validation protocols & reports for cleaning validation, process validation, Bulk Holding Time Validation, Media Fills , Air & Water system qualifications.
Review & approve the Equipment validation life cycle and its documents example: (URSs, IQ, OQ, PQ, VSR, decommissioning documents ,Thermal mapping & PVRs).
Lead the validation pharmacists & CSV Engineers for planning & coordinating the different Air system qualification, Media Fill runs, Process Validation, Cleaning validation & Equipment Validation activities and deliverables related to new and existing equipment’s and products.
Ensure all process and cleaning validation testing required for new and existing equipment’s and products are implemented according to process and cleaning validation plans.
Ensure that all air system qualification and media fill runs are conducted according to qualification plans.
Follow up validation review practices for scheduled equipment’s and products and review the validation review reports and follow up completion of relevant action plans.
Key Requirements:
Bachelor’s of pharmacy or engineering only
7-8 years experience in a similar role
Closing Date: 25.10.2023