Quality Assurance Section Head
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 activities related to validation for both sterile and non-sterile operations, ensuring all validation processes comply with regulatory and cGMP requirements.
- Ensure the planning, execution, and monitoring of validation activities across manufacturing processes and systems.
- Collaborate with manufacturing, engineering, and technical teams to ensure validated processes are maintained and continuously improved.
- Conduct internal audits and assessments of validation activities, documentation, and systems to ensure compliance and identify areas for improvement.
- Manage and coordinate CAPA (Corrective and Preventive Action) related to validation findings and quality issues, ensuring timely resolution.
- Support technology transfer and new product introduction, ensuring validation requirements are properly implemented.
- Lead training initiatives to enhance staff understanding of validation practices, sterile and non-sterile operations, and cGMP requirements.
Requirements
- Bachelor’s degree in Pharmacy, Chemistry, or a related field.
- 7–8 years of experience in Quality Assurance within the pharmaceutical industry, with strong expertise in validation activities for both sterile and non-sterile operations, including process validation, cleaning validation, and equipment qualification. Good understanding of cGMP and quality systems is required.
- Experience in managing teams and leading audits, strong experience in managing diverse customer requirements, technology transfer projects, and setting timely communication with customers.
- Excellent English, analytical, problem-solving, and communication skills.
- Proven ability to lead diverse teams across multiple geographical regions.
- Solid background in new product project management, technology transfer, and product launches in compliance with EU standards.