What the role is:The staff will be involved in the outreach engagement activities and enrolment of companies into the AMS; supporting HSA auditors (internal users of AMS) during the e-work process implementation; as well as continual improvement through monitoring and tracking of system performance/security, provision of relevant information to better guide the users, etc.What you will be working on:i. Conduct outreach engagement of existing licensed companies which are due for audit and new licence applicants, and their enrolment in the AMS. ii. Training of companies in the use of the AMS. iii. Monitor and track the DDOF/AMS system performance and security checks. iv. Review and revise self-help guide information (as needed) on HSA website. v. Assist in User Acceptance Test (UAT) of DDOF project, in the Stage 2 functional enhancement of the existing system and data integration of audit cases that were completed by the manual processes during the e-work process transition. vi. Exploring the integration of AMS into future Share/PRISM towards a more streamlined end-to-end GDP work processes. vii. Assist in the development of SOPs, guidelines, and forms viii. To perform any other duties as the ALD may reasonably require.What we are looking for:i. Possess knowledge/experience in scientific/technological discipline related to pharmaceuticals, e.g. pharmacy, pharmacology, toxicology, chemistry, chemical engineering, biochemistry, microbiology. ii. Preferably with 2 or more years of relevant experience in manufacturing and/or quality assurance/control in the pharmaceutical/ biopharmaceutical industry, and familiarity with the audit & licensing systemsAbout 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.
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