Requirements
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.
Description
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 SummaryWe 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: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).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.Ensure validation master plans, protocols, reports, and associated documentation are developed, reviewed, approved, and maintained in accordance with internal procedures and regulatory expectations.Collaborate with Manufacturing, Engineering, Quality Control, Technical Services, and other cross-functional teams to establish, maintain, and continuously improve validated processes and systems.Drive investigation, risk assessment, change control, and CAPA activities related to validation, ensuring timely implementation and effectiveness.Support technology transfer, new product introductions, process optimization, and facility expansion projects by ensuring validation requirements are effectively implemented.Ensure validation readiness for regulatory inspections and customer audits by maintaining compliant validation documentation and supporting inspection activities.Lead training initiatives to enhance staff knowledge of validation principles, sterile and non-sterile manufacturing processes, and cGMP requirements.