Quality Officer

JOB SUMMARY Working closely with the OUCRU Quality Manager, the Quality officer will: i) plan and implement ISO 15189 quality management system, in microbiology and biochemistry laboratories at Pham Ngoc Thach TB hospital. Supervise and implement document management system, instrument management system, Quality control and quality assurance system, laboratory health and safety system, and coordinate and provide training to laboratory staff) ii) Work as key contact person on all quality related issues at OUCRU. KEY TASKS AND RESPONSIBILITIES 1. Implement and maintain ISO 15189 document control system at PNT TB hospital. This includes the organization of documents, maintaining document control system. Support staff and investigators in drafting and writing manuals, policy, procedures, SOPs, work instructions. 2. Instrument record management: Support, supervise and monitor the activities to ensure that all instruments records are updated, complete and in compliance with ISO 15189. 3. Training: Support QA manager in coordination and conduct of the training; this includes but not limited to safety training, quality management related training, laboratory induction training and other ad-hoc training. 4. Support PNT hospital laboratories in implementing MoH Vietnam regulatory standards accreditation requirements, submit documents to relevant MoH authorities in a timely manner. Implement risk assessment and risk management of laboratory procedures, incident management program 5. Support PNT hospital and Quality manager in implementing the standards and guidelines for safe collection, appropriate decontamination and proper disposal of waste. 6. Support PNT hospital and Quality manager in conducting routine laboratory audit (specimen reception room, media and reagent preparation room, BSL2 laboratories, and storage facilities), follow up audit reports. Support in organizing Management review meetings, and implementation of corrective actions. 7. Support PNT hospital and Quality manager in implementing QA/QC process in all laboratory testing, analyze the QA/QC data, and implement corrective and preventive action. DEPARTMENT Laboratories Management Group LOCATION This post is based in Pham Ngoc Thach (PNT) TB hospital, Ho Chi Minh City. HOURS OF WORK 37.5 hours per week, extra hours may be required. TENURE Initially for 1 years, including a 2 month probation period. REPORTING TO Head of Laboratories REQUIREMENTS - Experience in conducting laboratory assessment, inspection and audits. - Experience in writing, reviewing audit reports. - Clear understanding of MoH, Vietnam laboratory regulation and guidelines. - A good team player and ability to motivate others for change management. ESSENTIAL CRITERIA BSc or MSc with atleast 2 year work experience in laboratory environment • Previous knowledge on GLP, GCLP • Experience in implementing quality management system in laboratories. DESIRED CRITERIA • Sound knowledge on ISO 9000, ISO 15189, ISO 17025, ISO 18001 … • Good negotiation and motivation skill, focus, goal oriented BENEFITS - Contracted salary: Negotiate (depending on actual experience and education). - Optional insurance : In-patient and out-patient medical coverage; Personal accident insurance coverage - Two months salary for annual bonus and clothes - Annual leave 18 days/year for the first year, a maximum of 30 days - Other responsibilities and benefits are based on Viet Nam Labor Law. HOW TO APPLY Interested qualified candidates are invited to send their detailed resume and cover letter in English, including copies of relevant degrees, certificates, either by email or by post to the following address: Oxford University Clinical Research Unit Laboratory of Clinical Science Hospital for Tropical Diseases 764 Vo Van Kiet, Ward 1, District 5, HCMC DEADLINE FOR SUBMISSION 10th Dec 2019 * We thanks all applicants for their interests but only short-listed candidates will be contacted for interview.

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