Quality Assurance Section Head - Validation

About the role

EVA Pharma, a leading pharmaceutical company, is looking for a Quality Assurance Section Head to lead its Quality Assurance Validation function for sterile and non-sterile operations. The role ensures validation activities comply with regulatory requirements and current Good Manufacturing Practices (cGMP).

Key responsibilities

• Lead the QA validation function for sterile and non-sterile operations, ensuring compliance with regulations and 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 and ongoing process verification.
• Ensure validation master plans, protocols, reports and documentation are developed, reviewed, approved and maintained.
• Collaborate with Manufacturing, Engineering, Quality Control, Technical Services and other teams to improve validated processes and systems.
• Drive investigation, risk assessment, change control and CAPA activities related to validation.
• Support technology transfer, new product introductions, process optimization and facility expansion projects.
• Ensure validation readiness for regulatory inspections and customer audits.
• Lead training on validation principles, sterile and non-sterile manufacturing and cGMP.

Required profile

• 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.
• Solid background in project management, technology transfer and product launches, especially for EU-regulated pharmaceutical products.
• Excellent command of English.

Required skills

• 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.
• Analytical, problem-solving, communication and leadership skills.