Job Description

Position Summary Responsible for Overall Drugs & Chemicals Management and its compliance activities in R&D and Manufacturing facility(ies) from Quality perspective, covering suppliers, manufacturing, lot release and post market aspects.

Position Responsibilities

• To master the Drugs & Chemicals related matters and develop oneself to become the \xe2\x80\x9cgo-to-person\xe2\x80\x9d in Quality;
• To lead and support the development of in house drug manufacturing capability;
• To manage and ensure sufficient supply of primary reference standard;
• To lead and own or provide guidance to other stakeholders on non-conformance investigations/CAPA pertaining to drug or chemical issues;
• To prepare validation protocols and reports and study reports related to drug and chemicals;
• To develop, qualify and manage drug and chemical suppliers (existing or alternate) and/or its issues at all cycle of product realization;
• To assist SQE on overall supplier management program, which includes onboarding, SCAR, audit & evaluation and change management related activities;
• To develop, implement and control the appropriate uses of quality tools and techniques in various reporting system, including graphs, charts or arithmetical analysis related to medical device research and development, product/process controls, performance and quality, to assist management in decision making;
• To develop, validate new and/or improve existing Inspection and Test methodology which complies to standards;
• To research on the latest metrology concept and technology, and consistently perform feasibility study to seek opportunities to integrate the new testing concept into in-house testing methodology based on theories, rationales, principles, rules, risk assessments and assumptions/literatures;
• To guide and ensure our laboratory to comply to relevant regulatory requirements

• Bachelor of Science/Pharmaceutical Science or Engineering with relevant Chemistry or Biomedical background;
• Preferred to have 2 years of relevant experience in QA, and in chemical/drug manufacturing environment;
• Able to communicate and read in English and Mandarin documents/ processes;
• Familiar with Microsoft Office Applications;
• Excellent interpersonal and communication skill and possess positive attributes;
• High level of integrity;
• Able to work under stress and deliver work schedules;
• Self-starter,independent, creative and innovative;
• Sound knowledge on applicable standards such as CGMP, ICH, US Pharmacopoeia and APIs; Knowledge on MDD (93/94/EEC) and MDR, ISO 13485 and QSR will be an added advantage and also knowledge of chemistry and related fields (organic, analytical chemistry, etc);
• Good analytical and problem solving skills;
• Familiar with Data integrity and other compliance associated with FDA or any relevant competent authority;
• Sound influencing, communication and project management skill will be an added advantage;