Job Openings Manager, Quality Assurance
About the job Manager, Quality Assurance
A leading pharmaceutical company.
- 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.
- 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.