Quality Assurance Section Head
On-site6th of October City, Giza, Egypt
Job Summary
Quality Assurance Section Head at EVA Pharma overseeing the validation function for sterile and non-sterile operations, including planning, execution, review and lifecycle management of validation activities (IQ/OQ/PQ, process and cleaning validation, utilities qualification, and computerized systems validation). Develop and maintain validation master plans, protocols, reports, and related documentation; collaborate with Manufacturing, Engineering, Quality Control, Technical Services, and other teams to sustain validated processes; drive investigations, risk assessment, change control, and CAPA; support technology transfer, new product introductions, process optimization, and facility expansion; ensure readiness for regulatory inspections and customer audits; lead training on validation principles and GMP requirements.
Required Qualifications
- Bachelor's degree in Pharmacy.
- 7–8 years of experience in Pharmaceutical Quality Assurance, with strong expertise in validation for sterile and non-sterile manufacturing, including process validation, cleaning validation, equipment qualification (IQ/OQ/PQ), utilities qualification, and validation lifecycle management.
- Strong knowledge of cGMP, regulatory requirements, quality risk management, change control, deviation management, and validation principles.
- Experience in technology transfer, new product introduction, qualification of new facilities/equipment, and validation strategy implementation.
- Excellent analytical, problem-solving, communication, and leadership skills.
- Excellent command of English.
- Solid background in project management, technology transfer, and product launches, particularly for EU-regulated pharmaceutical products.
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