Location6th of October City, Giza Governorate, Egypt
Work modeon-site
Typefull-time
DepartmentOperations Business Division
Company size1,001–5,000 people
First seen1w ago
Last seen1d ago
About the company
Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
Job Summary
We are seeking a passionate and talented Quality Assurance Section Head to join our dynamic team.
The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
Key Responsibilities:
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Lead the Quality Assurance Validation function for both sterile and non-sterile operations, ensuring all validation activities comply with regulatory requirements and current Good Manufacturing Practices (cGMP).
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Oversee the planning, execution, review, and lifecycle management of validation activities, including process validation, cleaning validation, equipment qualification (IQ/OQ/PQ), utilities, computerized systems validation (where applicable), and ongoing process verification.
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Ensure validation master plans, protocols, reports, and associated documentation are developed, reviewed, approved, and maintained in accordance with internal procedures and regulatory expectations.
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Collaborate with Manufacturing, Engineering, Quality Control, Technical Services, and other cross-functional teams to establish, maintain, and continuously improve validated processes and systems.
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Drive investigation, risk assessment, change control, and CAPA activities related to validation, ensuring timely implementation and effectiveness.
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Support technology transfer, new product introductions, process optimization, and facility expansion projects by ensuring validation requirements are effectively implemented.
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Ensure validation readiness for regulatory inspections and customer audits by maintaining compliant validation documentation and supporting inspection activities.
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Lead training initiatives to enhance staff knowledge of validation principles, sterile and non-sterile manufacturing processes, and cGMP requirements.
Requirements
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Bachelor’s degree in Pharmacy.
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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.
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Strong knowledge of cGMP, regulatory requirements, quality risk management, change control, deviation management, and validation principles.
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Experience in technology transfer, new product introduction, qualification of new facilities/equipment, and validation strategy implementation.
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Excellent analytical, problem-solving, communication, and leadership skills.
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Excellent command of English.
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Solid background in project management, technology transfer, and product launches, particularly for EU-regulated pharmaceutical products.