Job Description

What the role is:The officer will be required to contribute to the Audit & Licensing Division (ALD) Good Distribution Practice (GDP) functions, in the audit and processing of license applications for importers and wholesalers of health products, to ensure compliance with expected regulatory standards and requirements1. To perform critical assessment on licensees through conducting audits and licensing of therapeutic, medicinal and other health-related product dealers (e.g. importers, wholesalers) to protect public health.2. To perform critical assessment of dealer\'s license applications within the target timelines to determine company\'s compliance with the regulatory requirements and to provide recommendations for regulatory decisions of these applications.3. To assist in the implementation of Quality Management System (QMS) of the Audit & Licensing Division (ALD) in accordance with the PIC/S Quality System requirements for Pharmaceutical Inspectorates, to ensure that the regulatory functions of the organisation are in line with international practices.4. To handle complex enquiries and requests from applicants, industry stakeholders and members of the public to ensure appropriate clarifications are provided in a timely manner.5. To actively participate and lead in branch functions/projects and process/regulatory reviews to enable process efficiency and improvements.6. To perform such other administrative duties as the ALD may reasonably require.Job Requirements:

• Possess knowledge and experience in related scientific disciplines, e.g., pharmacy, pharmacology, pharmaceutical science, chemistry, biochemistry, microbiology).
• Preferably with personal experience in technical functions or operational work involving logistical handling/distribution of health products in the pharmaceutical or allied industries.
• Good working knowledge of GDP standards and local regulatory controls of health products.
• Preferably have experience in quality management systems (e.g. ISO 9001 QMS internal auditor).
• Demonstrate a positive attitude, possess good communications (oral & written), and able to contribute well as a team player.

About Health Sciences Authority:The Health Sciences Authority (HSA) applies medical, pharmaceutical and scientific expertise through its three professional groups, Health Products Regulation, Blood Services and Applied Sciences, to protect and advance national health and safety. HSA is a multidisciplinary authority. It serves as the national regulator for health products, ensuring they are wisely regulated to meet standards of safety, quality and efficacy. As the national blood service, it is responsible for providing a safe and adequate blood supply. It also applies specialised scientific, forensic, investigative and analytical capabilities in serving the administration of justice. For more details, visit http://www.hsa.gov.sg/. For more updates on public health and safety matters, follow us on Twitter at www.twitter.com/HSAsg and LinkedIn at https://sg.linkedin.com/company/health-sciences-authority.

Health Sciences Authority