Quality Assurance And Pharmacovigilance Officer

Quality System Management (QA)

Implement corrective and preventive actions (CAPA) to improve product quality.
Manage equipment calibration, maintenance, and change control for GSP/GDP operations.
Handle product quality issues, customer complaints, and product recalls. Investigate root causes and propose solutions.
Prepare for and participate in audits and self- inspections, including internal and external audits, and supplier evaluations.
Ensure all necessary product legal documents are up- to- date and organized.
Conduct incoming goods inspections and make release recommendations.
Monitor environmental conditions and manage quality incidents, including deviations and non- conformances.
Develop and improve the Quality Management System (QMS) based on Good Storage Practices (GSP), Good Distribution Practices (GDP), and Good Manufacturing Practices (GMP).

Pharmacovigilance (PV)

Conduct training on PV and ADR reporting for staff and medical representatives.
Participate in investigations of counterfeit drugs.
Respond to customer inquiries related to PV.
Manage all PV activities, including monitoring regulatory updates and coordinating with external partners.
Handle Adverse Drug Reaction (ADR) reports and other safety updates, ensuring timely submission to national authorities and partners.

Compliance & Operations

Organize and supervise drug destruction processes in compliance with regulations.
Ensure compliance with GSP and GDP regulations by preparing and submitting applications and reports to government authorities.
Regularly update company policies and procedures, including drafting and revising Standard Operating Procedures (SOPs).
Manage departmental assets, including budgeting and procurement.

Expertise: Deep knowledge of GSP, GDP, and PV.
Mindset: Highly responsible, detail- oriented, and able to work effectively under pressure.
Skills: Strong teamwork, communication, and project management skills.

Enery Boost counter to serve coffee/tea needs
Birthdays, condolences, visits, marriages, holidays (New Year, Lunar New Year, April 30, May 1, September 2, Hung King&039;s death anniversary, October 20, March 8, June 1, Mid- Autumn Festival,...)
Other benefits: Travel, Seniority bonus, Excellent employee bonus, 13th month salary + Performance bonus
PVI Health Insurance
Working location: Lot F14- 2- 2 & F14- 2- 3, Road 24, Hiep Phuoc Industrial Park, Hiep Phuoc Commune, Nha Be District, Ho Chi Minh City
Shuttle bus to work in District 7 and District 8
Opportunity to work long- term and develop at Gonsa
A decent lunch

Cập nhật gần nhất lúc: 2025-09-08 22:05:02