GMP Quality Assurance Manager – Drug-Device Systems

Health Hope Pharma Limited; Hong Kong; On-site; HKD 600,000 - 1,200,000; Full time

Job summary

Health Hope Pharma Limited in Hong Kong seeks a GMP Quality Assurance professional to support the quality management system and ensure compliance across manufacturing and testing activities.

You will manage deviations, CAPA, change control, OOS/OOT, and non-conformances, review records and COAs, and support regulatory readiness. Strong English documentation skills and experience with CDMOs are essential.

Qualifications

• Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Bioengineering, Chemistry, Life Sciences, Medical Devices or a related discipline.
• Three plus years of GMP quality assurance experience in pharma or related industry.
• Knowledge of deviation management, CAPA, change control, OOS, OOT, validation and quality risk management.
• Experience with CDMO and supplier quality management.
• Familiarity with FDA 21 CFR Parts 210-211, EU GMP or other international requirements.
• Understanding of medical device quality systems for drug-device products.
• Proficiency in English for technical review and communication.

Responsibilities

• Support the establishment, maintenance and continuous improvement of GMP quality management system.
• Manage deviations, CAPA, change control, OOS and OOT, non-conformances and quality complaints.
• Review batch manufacturing records, testing records, validation documents, COAs and quality agreements.
• Support R&D, technology transfer, process validation and manufacture of investigational products.
• Participate in qualification and auditing of CDMOs, contract testing labs and suppliers.
• Follow up on quality incidents and remediation activities involving external partners.
• Support quality management for drug-device products including syringes and delivery devices.
• Participate in device design changes, supplier changes, risk assessments and packaging validation.
• Support internal audits and readiness for regulatory inspections by authorities like NMPA, FDA and EMA.
• Regularly report significant quality risks and improvement recommendations to the CSO.

Skills

GMP quality assurance

Deviation management

CAPA

Change control

OOS/OOT

Validation

Quality risk management

CDMO and supplier quality

FDA 21 CFR Parts 210-211

ISO 13485 / QMSR knowledge

English documentation

Education

Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Bioengineering, Chemistry, Life Sciences or Medical Devices

Tools

eQMS

Job description

Health Hope Pharma Limited in Hong Kong seeks a GMP Quality Assurance professional to support the quality management system and ensure compliance across manufacturing and testing activities.

You will manage deviations, CAPA, change control, OOS/OOT, and non-conformances, review records and COAs, and support regulatory readiness. Strong English documentation skills and experience with CDMOs are essential.