عن الوظيفة
Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates.
Our purpose is to enable longer and healthier lives while creating sustainable growth.
We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets.
With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.
The Validation & Qualification Section Head is accountable for governance, review, and approval of all validation and qualification activities, including process, cleaning, equipment, utilities, and computerized systems, ensuring full GMP and regulatory compliance.
The role provides quality oversight across the validation lifecycle, ensures sustained compliance of environmental and support systems, supports risk assessments and regulatory gap analyses, and collaborates with Engineering, Production, and Quality functions to ensure effective and compliant execution of validation programs.
Your responsibilities:Review mapping activities (initial qualification and thermal mapping review).Review T&T implementation for managing validation of different activitiesProvide governance and approval of the equipment cleaning validation program.Oversight & review Process validation activities.Review HVAC, Compressed Air & Water System Qualification documents.To review testing results, viable and non-viable counts results.Review & approve Media Fill Simulation related documents.Ensure that media fill is conducted as per issued protocol.Ensure that all environmental systems and support equipment remain in full compliance.review different Qualification activities for machines, equipment and utilities.support risk assessments if needed.GAP analysis for CSV/ 21 CFR part 11 requirements with Eng.Assure qualification execution with Eng.Review Site Validation mater plan.Review Analytical Lab Qualification program.Assess equipment URS and ensure that quality, CSV and DI requirements are in placeAssure validation lifecycle documents.Review IPC lab Qualification & calibration with production& Eng.
Bachelor's degree in pharmaceutical sciences.Minimum 7 years' experience in a similar validation & qualification background, preferably in multinational pharmaceutical company.Fluent in Arabic and English.
Bachelor's degree in pharmaceutical sciences.Minimum 7 years' experience in a similar validation & qualification background, preferably in multinational pharmaceutical company.Fluent in Arabic and English.
