Winnie

Senior Quality Assurance and Pharmaceutical Professional with more than 13 years of progressive experience within pharmaceutical manufacturing and quality systems. Extensive experience in GMP compliance, batch release, stability studies, Quality Management Systems (QMS), deviation management, CAPA, change control, validation oversight and regulatory inspections. Recognized as an Authorized Person / Qualified Person responsible for the final disposition and release of commercial pharmaceutical products, ensuring compliance with GMP, PIC/s, FDA and internal quality requirements.

Proven ability to lead high-performing teams, drive continuous improvement initiatives, support successful regulatory inspections, and maintain robust quality systems. Seeking to contribute extensive quality and compliance expertise to a leading pharmaceutical organization in Australia.

Assistant Manager / Section Head – Plant Quality Assurance Operations - Unilab Inc. - Philippines

(2024-04 - 2026-04)

Led plant Quality Assurance operations across pharmaceutical manufacturing activities ensuring compliance with GMP requirements, internal quality standards and regulatory expectations

• Supervised daily QA operations teams responsible for batch review, quality documentation, and product release.
• Served as Authorized Person / Qualified Person responsible for final batch review, disposition and release of finished pharmaceutical products.
• Oversaw deviation investigations, CAPA implementation, change control systems and risk management activities.
• Ensured ongoing compliance with GMP, GLP, GDP, PIC/s Guidelines, FDA requirements and company quality standards
• Handled and approved stability studies of drug products for registration
• Supported regulatory inspections and audits with successful outcomes
• Provided strategic initiatives to quality leaders to improve operational effectiveness and compliance performance
• Acted as key quality decision-maker for product disposition and release activities

Quality Assurance Officer - Unilab Inc. - Philippines

(2023-06 - 2024-03)

Quality Assurance Supervisor - Unilab Inc. - Philippines

(2019-06 - 2023-06)

Associate Quality Assurance Inspector II - Unilab Inc. - Philippines

(2015-12 - 2019-06)

Associate Quality Assurance Inspector - Unilab Inc. - Philippines

(2013-02 - 2015-12)

Pharmacist - Watsons - Philippines

(2011-04 - 2012-04)

• Supervised daily pharmacy operations
• Dispensed prescription medications accurately and provided professional medication counseling to customers
• Served as pharmacist-in-charge, ensuring adherence to pharmacy laws, company policies and regulatory guidelines
• Assisted in achieving pharmacy sales targets through effective product recommendations and health category management

Bachelor of Science - Pharmacy - Mariano Marco State University (2010)