Deputy Quality Manager

Job Purpose
The Deputy Quality Manager is responsible for supporting the Quality Manager in establishing, maintaining, and improving the Quality Management System (QMS) in compliance with GMP and relevant ISO standards. The role focuses on ensuring cleanroom production quality, regulatory compliance, and continuous improvement during the expansion of medical device manufacturing.
Quality Management & Compliance

Participate in preparing, implementing, and updating SOPs, quality manuals, and related documentation.
Assist in managing and maintaining the Quality Management System in compliance with GMP and ISO standards (ISO 13485 / ISO 13484 as applicable).
Ensure all production activities meet regulatory and internal quality requirements for medical devices.

Cleanroom Management

Oversee and manage ISO Class 8 cleanroom operations in accordance with GMP requirements.
Supervise validation, qualification, and routine monitoring of cleanroom facilities and equipment.
Ensure cleanroom standards (environmental monitoring, hygiene, contamination control) are strictly followed.

Audit & Inspection Support

Prepare audit reports, manage corrective and preventive actions (CAPA), and ensure timely closure of non- conformities.
Support internal audits, external audits, and inspections by regulatory authorities and certification bodies.

Training & Supervision

Support the Quality Manager in supervising quality personnel and coordinating cross- functional activities.
Provide GMP, ISO, and cleanroom compliance training to production and quality staff.

Education : University degree in Pharmacy (Licensed Pharmacist preferred).
Experience

Strong understanding of GMP requirements related to cleanroom operations and medical device production.
Proven experience in cleanroom management, preferably ISO Class 8.
Experience working with GMP- certified manufacturing environments.
Practical experience with ISO 13485 (or ISO 13484 as required) standards for medical devices.

Skills & Competencies

Ability to work under pressure in a regulated manufacturing environment.
Strong knowledge of GMP and cleanroom quality standards.
Good documentation, audit, and regulatory compliance skills.
Leadership, coordination, and problem- solving abilities.

Salary & Benefits

Professional working environment in a growing medical device manufacturing company
Salary: Negotiable based on capability and experienceRange: 35 – 45 million VND/month
Opportunities for career development and advancement
Candidates currently living or able to live long- term in Hai Phong- proximity to the company is an advantage

Chế độ bảo hiểm, Du Lịch, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương

Cập nhật gần nhất lúc: 2026-01-06 06:50:02