Dana Rae Roldan

Licensed Pharmacist with 6+ years of experience in pharmaceutical quality assurance, regulatory compliance, GDP/GSDP operations, and pharmaceutical supply chain quality management. Experienced in Quality Management Systems (QMS), Good Distribution Practices (GDP), ISO 9001 compliance, deviation management, CAPA, internal audits, document control, product release, and regulatory inspection support. Strong background in pharmaceutical warehousing, clinical trial materials (CTM), cold chain operations, repackaging activities, and quality compliance monitoring.

Skilled in supporting FDA Philippines regulatory requirements, maintaining controlled documentation, conducting investigations, implementing corrective actions, and collaborating with cross-functional teams to ensure product quality, patient safety, and operational compliance.

Quality Assurance Specialist - Metro Drug Inc.

(2022-11 - 2025-04)

• Managed quality assurance activities for pharmaceutical warehousing and distribution operations in compliance with GDP, GSDP, QMS requirements, and applicable FDA regulations.
• Reviewed and monitored storage, handling, distribution, and product release activities to ensure compliance with approved quality standards and regulatory requirements.
• Performed pharmaceutical product release activities through SAP based on quality documentation, specifications, and established procedures.
• Managed quality investigations including deviations, root cause analysis, corrective and preventive actions (CAPA), and effectiveness checks.
• Conducted internal audits and supplier audits to evaluate compliance with company procedures, GDP requirements, and quality standards.
• Supported continuous improvement initiatives through quality performance monitoring, compliance gap identification, and process improvement recommendations.
• Reviewed, updated, and implemented SOPs, work instructions, and controlled quality documents.
• Facilitated GMP/GDP awareness training and compliance programs for warehouse and operational personnel.
• Supported regulatory inspections, client audits, and quality assessments by ensuring availability and accuracy of quality records.
• Oversaw cold chain operations and medical device quality activities to maintain product integrity throughout distribution.
• Served as Backup Document Controller and Internal Auditor, ensuring compliance with document management procedures, record retention, and data integrity requirements.

Quality Assurance Associate - Zuellig Pharma Corporation

(2021-06 - 2022-11)

• Supported Quality Assurance operations for Clinical Trial Materials (CTM) warehousing and pharmaceutical distribution activities.
• Reviewed receiving, storage, repackaging, handling, and distribution processes to ensure compliance with GDP, GCP requirements, client specifications, and quality procedures.
• Maintained Quality Management System documentation including controlled documents, records, and quality compliance files.
• Performed document control activities including document issuance, tracking, review, and retention.
• Supported investigations, deviation management, CAPA implementation, and risk assessment activities.
• Conducted GDP and quality compliance training for warehouse personnel to strengthen operational compliance.
• Assisted during client audits, regulatory inspections, and quality assessments by preparing documentation and compliance records.
• Collaborated with Supply Chain, Operations, and Quality teams to ensure consistent implementation of quality standards.

Company Pharmacist - The Neodrugstore Inc.

(2019-05 - 2021-03)

• Ensured compliance with pharmaceutical regulations, pharmacy standards, and company quality procedures.
• Managed regulatory documentation related to returned, recalled, and regulated pharmaceutical products.
• Maintained pharmacy records, controlled documents, and regulatory files in accordance with applicable requirements.
• Supported quality compliance activities related to product handling, storage, and documentation management.

Medical Promotion Specialist - Zuellig Pharma Corporation

(2016-06 - 2018-01)

• Conducted ethical and compliant pharmaceutical product discussions with healthcare professionals.
• Delivered scientific product education while ensuring compliance with company policies and industry standards.
• Supported medical programs, product launches, and healthcare education initiatives.

Bachelor of Science - Pharmacy - Virgen Milagrosa University Foundation (2015) San Carlos City, Pangasinan