Key Responsibilities 主要職責:

1. To lead GMP license application.
2. To in charge of the technical transfer from other corporation companies.
3. To create the QMS for GMP.
4. To lead the facility, Equipment, product qualification and associated validation.
5. To ensure the company complies with the principles and practice of current GMP and Quality Assurance (QA) as given in the current PIC/S Guide to GMP, including related Hong Kong legislation;
6. To ensure the company complies with the conduct and obligations of holders of a manufacturer license and registration certificates for pharmaceutical products;
7. To prepare for and management of regulatory GMP inspections;
8. To ensure the tools and methods used for risk management and their interface complied with regulatory requirements;
9. To meet the requirements for APs when acting as independent contractors or on behalf of third parties.
10. To ensure the key factors, information or metrics that confirm a batch of pharmaceutical product has a suitable pedigree demonstrated throughout the manufacturing supply chain and has been manufactured according to current PIC/S GMP requirements;
11. To verify and certify or reject that each batch produced after GMP license approval.
12. To ensure the application of risk management within the company.

Requirements 職位要求:

• Be a registered pharmacist in Hong Kong Pharmacy and Poison Board;
• Be a registered Authorized Person in Hong Kong Pharmacy and Poison Board;
• at least 3 years of relevant practical experience in GMP pharmaceutical manufacturing and/or quality control (at managerial or supervisory level) in one or more pharmaceutical manufacturers.
• Relevant GMP pharmaceutical manufacturing experience of sterile products;