The Quality Validation  Associate Manager leads the company’s validation program to ensure all storage facilities, equipment, and distribution processes consistently meet GSP and GDP standards. This role is responsible for driving validation excellence, maintaining data integrity, and supporting a reliable pharmaceutical supply chain.

1. JOB DESCRIPTION (KEY RESPONSIBILITIES)

• Develop, maintain, and oversee the Validation Master Plan (VMP) and annual validation schedules.
• Define risk-based lifecycle validation requirements (DQ, IQ, OQ, PQ) and evaluate operational changes, deviations, or new requirements to determine re-validation needs and budget allocation.
• Lead temperature and humidity mapping activities for storage areas, including ambient warehouses, cold rooms, and quarantine zones under various stress conditions (e.g., loaded/empty, seasonal changes, power outages).
• Qualify critical infrastructure, including HVAC systems, freezers, thermal packaging solutions, and computerized systems (WMS, BMS, and alarm monitoring systems).
• Design and execute cold chain transportation validation activities to ensure temperature stability throughout distribution.
• Prepare, review, and approve validation documents, including URS, risk assessments, protocols, reports, and supporting records.
• Investigate deviations, manage CAPAs, and ensure timely resolution of validation-related issues while maintaining data integrity.
• Serve as the Subject Matter Expert (SME) during internal audits, customer audits, and regulatory inspections related to GSP/GDP compliance.
• Train, coach, and develop validation team members to ensure high-quality execution and safety compliance, while collaborating with QA, IT, Warehouse Operations, Engineering, and external vendors to drive continuous improvement.

2. JOB REQUIREMENTS

• Bachelor’s degree in Pharmacy, Engineering, Chemistry, Biotechnology, or a related field. A University Degree in Pharmacy is highly preferred.
• Minimum 5 years of experience in Quality Assurance, Validation, Pharmaceutical Warehousing, or Cold Chain Logistics.
• At least 1–2 years of project coordination and/or team leadership experience.
• Strong knowledge of GSP/GDP standards, validation lifecycle management, Quality Risk Management (QRM), and temperature-controlled storage and transportation systems.
• Proven experience in developing validation protocols, conducting validation activities, and analyzing temperature and humidity data.
• Strong analytical and problem-solving skills with the ability to investigate deviations, assess change impacts, and implement corrective actions.
• Excellent communication, stakeholder management, and cross-functional collaboration skills.
• Proficiency in Microsoft Office applications and validation documentation management.

3. BENEFITS

• Competitive salary package and annual performance bonus.
• 13th-month salary and comprehensive healthcare benefits.
• Annual health check-up and employee healthcare programs.
• Continuous training, professional development, and clear career advancement opportunities.
• Annual company trip and employee engagement activities.
• Professional, transparent, and data-driven working environment.

Work Location: Gonsa Head Office, Hiep Phuoc Industrial Park, Nha Be District (Shuttle bus service available from old District 7 and District 8).

Working Hours: Monday - Friday (8:00 AM - 5:30 PM)