Main Responsibilities
Thailand
- Be the licensed pharmacist and licensed holder for the local affiliate in Thailand, with the following responsibilities:
- to display the modern drug import license and the pharmacist license at the importer's office as well as the required signages to ensure that a pharmacist-on-duty is stationed at the importer's office or drug warehouse during operating hours
- to ensure that the company complies with the applicable standards relating to Good Distribution Practice
- Release activity for Thailand as per Thai FDA requirements.
SEA
- Manage, oversee or act as subject matter expert for regulatory inspections, complaints, deviations, recalls, counterfeits and product tampering according to the BeiGene quality system procedures
- Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
- Provide quality deliverables for successful new product introductions including distribution readiness.
- Provide expert quality input to strategic decision making, including launch readiness, recall, external communications, and product impact decisions
- Establish quality priorities or budgets and allocate resources and workloads.
- Develop and maintain standard operating procedures or local working practices.
- Maintain current knowledge of relevant regulations, including proposed and final regulations.
- Oversee the quality budget in the SEA affiliates.
- Ensure local activities comply with relevant GDPs and Quality Management System including warehouse, distribution and Lab management, support relevant GDP activities in SEA.
- In country disposition / release activities for SEA.
- Qualification and oversight of 3rd party GMP/GDP service providers – audits, quality agreements, monitoring activity, participate in KPI and business reviews
- Participate / respond to corporate audits and self -assessments for responsible countries
- Management of temperature sensitive products including lane qualifications, shipper qualification, temperature excursion assessments, transport validation
- Support for new products launch
- GxP training content development and delivery as required for SEA staff
- Contribute and participate in the regional/global management review, support other countries
- Participate in the Annual Product Review as required by local requirements
- Quality input into business development, tenders or national formulary as required.
Supervisory Responsibilities
Qualification Required
Education Required:
Life Sciences or equivalent tertiary degree or direct relevant experience to complete required responsibilities. Thai language capabilities.
