Job Description

What the role is:To provide support to ALD in managing and improving the file registry processes to meet IM4L and NAS requirements and in maintaining the documentation of ALD's certified quality management system in accordance with international standards.What you will be working on:The Regulatory Executive/Senior Regulatory Executive (SRE) will be required to provide support to the Audit & Licensing Division (ALD) in the following areas: 1) Administrative support to address the opportunity for improvements (OFI) and gaps in accordance with IM4L and NAS requirements: xe2x80xa2 Implementation of approved File Plan (e-registry) for ALD. xe2x80xa2 Organise and classify all existing ALD electronic records that are archived in SharePoint Fileshare (SPFS) for filing in the approved file plan folders. xe2x80xa2 Manage the destruction of expired physical file records. xe2x80xa2 Coordinate the transfer of relevant files (to be converted electronically) to the National Archives of Singapore (NAS). 2) Support in maintaining ALD's Quality Management System (QMS) for compliance with international standards: xe2x80xa2 Coordinate logistics for internal and external audits (e.g., ISO9001:2015 audits, HSA's internal audits) xe2x80xa2 Track and facilitate the resolution of (Potential) Non-Conformities. xe2x80xa2 Compile and update quality improvement and regulatory performance metrics xe2x80xa2 Assist in QMS maintenance to meet HSA's obligations as WHO -designated ML4 regulatory authority, WLA, and PIC/S participating authority.What we are looking for:

• Candidate with no work experience is welcome to apply. xe2x80xa2 Candidate with some work experience in regulatory environment, audit-related work or in pharmaceutical or healthcare industry would be an advantage. xe2x80xa2 Proficiency in Microsoft Office applications and other relevant computer software xe2x80xa2 Good oral and writing communication skills xe2x80xa2 Positive attitude and ability to work effectively as a team player. xe2x80xa2 Strong organisational and analytical skills xe2x80xa2 Attention to detail and ability to manage multiple projects

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