At Lilly-NUS, our mission is the conduct of clinical pharmacology research studies. In particular, our emphasis has been in early phase and biomarker clinical studies. Over the last 10 years, we have focussed on therapies and investigations in metabolic and neuroscience arenas. Our location in multi-ethnic Singapore also presents us an opportunity to study ethnicity as a factor in drug action. We now have the following opportunities for interested individuals to join us and work in an interesting and dynamic environment.

Responsibilities:
The Area Quality Assistant (AQA) provides administration support to the Area Quality Coordinator in the management of quality systems and training administration.
The AQA is responsible to maintain and improve administrative quality systems within the organization and lead administrative implementation of quality processes/procedures within LNUS. The AQA is also responsible for adherence to GCP in relation to administration of quality systems (Quality Management System documents/Training).

QUALITY MANAGEMENT SYSTEM (QMS) DOCUMENT ADMINISTRATION
• Maintain QMS electronic database and hard copy at central locations.
• Provide administrative support (including QC and version control) for the creation and update of QMS documents, and retirement of QMS documents.
• Coordinate QMS document review/approval.
• Maintain SOP deviation-tracking tool.

TRAINING ADMINISTRATION
• Responsible for the release management of local QMS documents and other training courses.
• Responsible for raising request on creation of BET ID for local QMS documents and setting up of electronic acknowledgement.
• Maintain all documentation related to setting up and revision of staff Individual Training Plan (ITP) in SAP/LEADS.
• Coordinate and develop new training documents for new roles in collaboration with the HODs.
• Maintain Individual training folder.
• Ensure correct filing of all training documents.
• Act as the EPM representative in the Global Medical Curriculum Governance Council.

PERSONNEL RECORDS MANAGEMENT
• Manage organization chart update and maintain revision history.
• Coordinate job description review, maintain and update job descriptions.
• Maintain the signature log.

COMPLIANCE AND QUALITY IMPROVEMENT
• Monitor training compliance and produce quality metrics.
• Help to identify gaps and issues in administrative quality processes, procedures and tools within LNUS QMS system.
• Perform, support and record periodic self-assessment activities.
• Liaison with global colleagues for synergy in quality development.

OTHER
• Maintain company's Quality and Training websites.

Requirements:
• Diploma/Degree holder with 2 to 3 years experience in a similar capacity. Having GxP knowledge is advantageous. Those with prior quality management experience will be beneficial
• Is meticulous and detailed oriented.
• Enjoys documentation, planning and organising work
• Is a self-starter and have the confidence to interact with people at all levels. Ability to work independently as well as with a team under tight deadlines
• Proficiency in Microsoft Office package is a pre-requisite
• Highly organizational management skills
• Proactive/self-starter
• Good communication skills
• Some flexibility with working hours required

Please submit your curriculum vitae giving qualifications, experience, personal details and expected salary. Only shortlisted candidates will be notified.

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