About Me – Alaiz Pharma Consultancy

Welcome to Alaiz Pharma Consultancy (APC), where I bring over a decade of specialized expertise in pharmaceutical quality assurance and compliance to empower your organization. As a dedicated freelance Quality Officer Consultant, I am passionate about enhancing quality systems, ensuring regulatory compliance, and delivering measurable results. My mission is to provide flexible, reliable, and hands-on QA support, helping pharmaceutical companies navigate complex challenges with precision and confidence.

BSc in Pharmaceutical Business Administration – University of Applied Sciences Utrecht has
equipped me with a strong foundation in pharmaceutical operations and business management.

My Journey

With more than ten years in the pharmaceutical industry, I have honed a deep understanding of quality management and regulatory frameworks. My career includes impactful roles at industry leaders such as Eurocept Pharma, Janssen Biologics, and TEVA Pharmachemie, where I contributed to high-stakes projects, including quality assurance for COVID-19 vaccine production.

These experiences have equipped me with the skills to thrive in dynamic, high-pressure environments while maintaining an unwavering commitment to quality and safety.

What I Do Best

I specialize in streamlining batch release processes, resolving audit findings, and eliminating operational backlogs. My strength lies in conducting thorough deviation analyses, leading robust root cause investigations, and implementing effective Corrective and Preventive Actions (CAPAs).

By combining technical expertise with a detail-oriented and results-driven approach, I ensure sustainable improvements that align with global standards.

Work Experience

QA Officer GDP – Ferring Pharmaceuticals, Hoofddorp
Apr 2024 – present
Temporary support for the QA team to promote company growth.

• Performing Technical releases for shipments
• Changing the status of medicines based on rigorous quality assessments
• Managing Technical Agreements with external partners
• Creation and handling deviations with the necessary corrective and preventive actions
• Coordinated and maintained accurate customer records in compliance with company policies and regulatory requirements
• Creating and handling change controls and ensuring that all the actions are managed and closed
• Create new customer records if needed
• Updating procedures and developing new procedures if needed
• Creating, revising documents in Veeva QualityDocs
• Supporting the qualification of new customers in accordance with GDP and internal procedures
• Reviewing and assessing customer qualification documentation (e.g. questionnaires, licenses, and GDP compliance evidence)
• Liaising with customers and internal stakeholders to ensure complete and compliant qualification files
• Tracking qualification status and ensuring timely follow-up on missing or expired documents