Local Parmaceutical Manufacturers
There are currently 30+ local pharmaceutical manufacturers in Hong Kong which mainly supply medicines to the local and mainland markets, and some export to overseas.
The quality function of a GMP manufacturer normally comprises of 4 departments: Quality Assurance (Q.A.), Quality Control (Q.C.), Production and Engineering & Maintenance. In some cases, the Regulatory Affairs (R.A.) might be separated from the Q.A. function and structured as a fifth department. Most of the pharmacists work in the Q.A. and R.A. Department to oversee the quality system, product quality and product registration.
Due to the recent mandatory upgrade to the international GMP standard – PIC/s, many quality upgrade projects are initiated and handled by the newly formed Compliance Team and Project Team on the establishment of the new up-to-standard GMP factories; design and implementation of quality management system and various quality aspects on validation, equipment, etc… Opportunities are available for the pharmacists with past experience working in the GMP manufacturers.
Medicinal product is considered as critical consumables for treating patients and saving lifes, the manufacturing activities are highly controlled both nationally and locally in order to safeguard the public health by achieving the highest quality standard for human use. The Q.A. function has a responsibility to ensure all manufacturing processes of medicine have been performed under a highly controlled environment. Briefly, the Q.A. frontline team involves in monitoring each manufacturing process, including the personnel, equipment, environment, method, facility, material, to ensure the intermediate and product produced are in good quality, and the manufacturing environment is appropriate for running every production.
In order to reduce the risk of products with compromised product quality, excellent systems, validated work instructions and approved processes shall be in place before any manufacturing process takes place. Continuous development and improvement is required to streamline every process step involved in facility to minimize contaminations, from managing the raw material suppliers to controlling the distribution of medicines, hence a large amount of documentations are generated everyday to prove the scientific methods and to provide clear instructions and training to the frontline staff for performing their tasks consistently.
Check out A Day in the Life of a Q.A. Manager in a Hong Kong Pharmaceutical Manufacturer to feel the day-to-day working life of a Q.A. Manager.
Pharmacists with 3 or more years of Q.A. / Q.C. / P.D. experiences working in GMP manufacturers are eligible to apply as the Authorized Person (A.P.), who will represent the manufacturer as quality head and oversee all the quality functions. One of his / her major authority is to approve and release the manufactured product batches for sale. Becoming a successful A.P. is a very important milestone to pharmacists who are dedicated to develop their career in the pharmaceutical manufacturer. One has to carry much more responsibilities and obligations as stipulated under the pharmacy and poisons ordinances.
Pharmaceutical products are clearly classified into different categories by the drug office. Medicines in most of the categories need registration with the regulatory agency before entering the local market. Regulatory affairs in local manufacturers normally deal with various change of particulars of registered medicines, which involves interaction with the sales and marketing team, designer team, quality functions team and regulatory agencies in order to submit the comprehensive applications for approval. It should be noted that a pharmacy degree is not mandatory for this position, although pharmacists are equipped with good knowledge of medicine information, regulatory ordinances and clinical therapeutics of drugs.
Multinational Pharmaceutical Companies
Multinational companies such as Pfizer and GSK often have established their APAC regional offices in Hong Kong. Opportunities such as Medical Representatives / Sales, Medical Affairs, Regulatory Affairs, Q.A. Operation Managers are available. On the other hand, Contract Research Organizations (CRO) are increasing their presence in Hong Kong to conduct clinical trials especially on the health conditions that are commonly seen in southern Asians. Clinical scientists, statisticians and data analysts are some of the opportunities in this field.
Sharing of the Role of Q.A. Associate in Multinational Pharma
Sharing of the Role of Regulatory Affairs and Quality Pharmacist in MNC
Local Wholesaler and Distributors
Wholesale distributors are one of the key players in the medicine supply chain, giant companies such as Zuellig, DKSH and LF Asia have acquired warehouses and delivery teams to provide specialised logistics services for manufacturers to distribute their products to end customers such as hospitals, pharmacies and clinics. On the other hand, wholesalers who import and export medicines to Hong Kong require supports from regulatory affairs to liaise with the regulatory agency on medicine license variations and issues. Opportunities are also available for pharmacists in these companies.