Manager, Quality Assurance

Hong Kong Executive Search; Hong Kong; On-site; HKD 900,000 - 1,400,000; Full time

Job summary

Hong Kong Executive Search is seeking a Manager, Quality Assurance in Hong Kong. You will lead QA and Validation teams, maintain the QMS, and ensure compliance with GMP, PIC/S and GAMP5 standards.

The role requires close work with Production and Engineering to validate processes, equipment, and facilities. The ideal candidate has a science degree (pharmacy preferred) and 5+ years in quality management and validation, with strong English and Chinese communication, and the ability to handle audits

Qualifications

• Degree holder or above in science, preferably Pharmacy.
• 5+ years of experience in Quality Management and Validation.
• Authorized Person qualification per HK Pharmacy and Poisons Board is a plus.
• Familiar with PIC/S, GAMP5 and GMP requirements.

Responsibilities

• Managing and supervising QA and Validation teams for daily operations and projects.
• Maintain QMS including document control, change control, deviation and risk management.
• Evaluate and maintain vendor qualification programs.
• Handle product complaints and returns related to quality.
• Provide quality trainings and maintain training database under GMP system.
• Collaborate with Production, Engineering and QC to develop and execute validation protocols.
• Coordinate process validation and cleaning validation for company facilities.
• Perform ad-hoc tasks as requested.

Skills

Quality Management

Validation

Documentation control

Communication

Problem-solving

Education

Science degree or above (Pharmacy preferred)

Tools

PIC/S knowledge

GAMP5 knowledge

GMP knowledge

Job description

About the job Manager, Quality Assurance

A leading pharmaceutical company.

Location

Hong Kong

Responsibilities

• Managing and supervising Quality Assurance Team and Validation Team of the company for daily operations and project-based tasks.
• Maintaining quality management system (QMS) which includes document control, change control, deviation & risk management system, etc.
• Responsible for evaluation and maintaining the vendor qualification program.
• Handling product complaints and returns related to product quality.
• Responsible in providing quality related trainings and maintains the training database under the GMP quality system.
• Work closely with Production, Engineering and Quality Control Departments to develop and execute validation protocols for new and existing equipment, facility and utilities.
• Managing and coordinating process validation and cleaning validation works of the company.
• Handling any administrative and ad-hoc tasks as assigned.

Requirements

• Degree holder or above in science subjects, preferably in Pharmacy.
• 5+ year's relevant working experience in Quality Management and Validation is required.
• Candidate with Authorized Person Qualification according to Hong Kong Pharmacy and Poisons Board is an advantage.
• Familiar with PIC/S, GAMP5 & GMP requirements.
• Self-motivated, well-organized, with good communication and problem-solving skills
• Strong Problem-solving skill and work well under pressure
• Good command of written and spoken English and Chinese.