Quality Validation Associate Manager

Company Description

GONSA Joint Stock Company, founded on March 8th, 2010, is a pioneering provider of healthcare logistics and distribution services. The company offers distribution solutions through hospital and pharmacy channels, ensuring efficient delivery of healthcare products. GONSA operates GSP-compliant storage services, including ambient and cold-chain warehouses, and provides transport and delivery services that meet GDP standards. The organization also delivers authorized importation and distribution importation services, warehouse rental, and other value-added offerings, supporting a comprehensive supply chain for healthcare partners.

Position Summary

The Quality Validation Associate Manager drives the company’s validation program to ensure all storage facilities, equipment, and distribution processes consistently meet GSP and GDP standards. By championing a risk based approach and strict data integrity, this role ensures our pharmaceutical supply chain operates flawlessly, safely, and efficiently.

Working location: Hiep Phuoc Industrial Park, Hiep Phuoc Commune, Ho Chi Minh

Core Responsibilities

1. Program Management & Strategy (20%)

• Master Planning: Develop, maintain, and oversee the Validation Master Plan (VMP) and annual validation schedules.

• Risk-Based Strategy: Define lifecycle validation requirements (DQ, IQ, OQ, PQ) tailored to specific equipment and systems.

• Change Control: Evaluate the impact of operational changes, system deviations, or new requirements to determine re-validation needs and budget allocation.

2. Technical Implementation: Facilities, Equipment & Cold Chain (40%)

• Facility Mapping: Lead temperature and humidity mapping for all storage zones (ambient, cold rooms, quarantine) under various stress conditions (e.g., loaded/empty, seasonal changes, power outages).

• Equipment Validation: Qualify critical infrastructure, including HVAC, freezers, thermal packaging, and computerized systems (WMS, BMS, alarm networks).

• Cold Chain Logistics: Design and test cold chain delivery routes and packaging configurations to guarantee temperature stability during transit, regardless of external variables.

3. Quality Compliance & Documentation (20%)

• Documentation: Author, review, and approve URS, risk assessments, protocols, and validation reports.

• CAPA Management: Investigate deviations, manage Corrective and Preventive Actions (CAPAs), and resolve out-of-specification results before releasing systems for routine use.

• Audit Readiness: Maintain meticulous, traceable records to ensure complete data integrity and act as the subject matter expert during internal, client, and regulatory GSP/GDP audits.

4. Team Leadership & Collaboration (20%)

• Mentorship: Train, guide, and evaluate validation team members to ensure high-quality execution and safety compliance.

• Culture Building: Foster a transparent, proactive team environment focused on early risk identification and data-driven decision-making.

• Cross-functional Coordination: Partner seamlessly with IT, Warehouse Operations, and external vendors to streamline validation activities.

Qualifications

• Education: Bachelor’s degree in Pharmacy, Engineering, Chemistry, Biotechnology, or a related field. A University Degree in Pharmacy is highly preferred.

• Experience: 8+ years of experience in Quality Assurance, Validation, Pharmaceutical Warehousing, or Cold Chain logistics, including at least 2 years of hands-on project owner or team leadership.

• Industry Knowledge: Deep understanding of GSP/GDP standards, validation lifecycles, Quality Risk Management (QRM), temperature-controlled storage and transport principles, and Computerized System Validation (CSV) compliance (GAMP 5, 21 CFR Part 11, and Data Integrity controls).

• Technical & Analytical Skills: Proven ability to design validation protocols, analyze temperature and humidity data, inspect and audit automated/computerized systems (WMS, ERP, EMS), investigate operational deviations, assess change impacts, and author rigorous, evidence-based reports.

BHXH, BH sức khỏe toàn diện, du lịch, teambuidling, khám sức khỏe và nhiều chế độ đãi ngộ khác

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