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.