- 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.
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:
- 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.
