We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters. Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference. Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward. If you care differently, you belong here. **MISSION / POSITION SUMMARY** Ensure that pharmaceutical manufacturing operations and Quality Systems at manufacturing sites comply with cGMPs, applicable regulatory requirements, and Almirall’s corporate Quality policies, thereby guaranteeing patient safety, product efficacy, and pharmaceutical quality. **RESPONSIBILITIES** * Ensure compliance with GMPs in manufacturing, packaging, and quality control activities. * Review and approve operational documentation for pharmaceutical manufacturing and testing, including procedures, manufacturing and packaging instructions, analytical methods, specifications, batch manufacturing records, or other related documentation. * Review documentation generated during plant processes, verifying its correct completion and conformity with established requirements. * Conduct periodic internal audits to verify the level of GMP compliance and participate in customer audits and regulatory inspections. * Evaluate the impact on product quality and GMP compliance of proposed changes. * Participate in the investigation and evaluation of deviations, quality incidents, market complaints, and other non-conformities, ensuring robust analysis and risk-based decision-making. * Track corrective and preventive actions (CAPA), verifying their implementation and effectiveness. * Review the records comprising the Batch Manufacturing Record to ensure conformity prior to certification and market release. * Support certification and batch release activities in accordance with applicable regulations. * Promote compliance with health, safety, and environmental standards, identifying risks and proposing improvement actions. * Drive continuous quality improvement in line with ICH Q10 principles and a risk-based management approach. * Foster a strong quality culture, data integrity, regulatory compliance, and patient orientation across the organisation. Collaborate cross-functionally with various operational areas to promote operational excellence and quality-driven decision-making. * **EDUCATION AND EXPERIENCE REQUIRED** * Bachelor’s or Master’s degree in Pharmacy. University degrees in scientific disciplines meeting the educational requirements for acting as a Qualified Person (QP) under applicable European and Spanish regulations will also be considered. * Solid knowledge of GMPs. * Minimum 1 year of experience in QA, production, and/or quality control within the chemical\-pharmaceutical sector. Advanced level of English. * **SKILLS AND COMPETENCIES** * Ability to review and approve technical documentation. * Strong risk-based decision-making capability. * Skills in managing deviations, CAPAs, audits, and regulatory inspections. * Analytical thinking and problem-solving ability. * Orientation towards continuous improvement and operational excellence. * Competence to work in regulated, dynamic, and multicultural environments. * Excellent communication, teamwork, and stakeholder management skills.
David Muñoz
Indeed · HR
David Muñoz
Indeed · HR
