Quality Officer

The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. 

OUCRU’s vision is to have local, regional and global impact on health by leading a locally driven research programme on infectious diseases in Southeast Asia. Priority is given to health issues important to the hospitals where we work, and to the countries as a whole where we operate: Vietnam, Indonesia and Nepal.  All work is intended not only to benefit the patients seen daily at our host hospitals, but also to help improve patient care.

Oxford University Clinical Research Unit (OUCRU) Nepal was founded in 2003 and has since established a reputation as one of the leading clinical research groups in Nepal. There has been considerable investment in upgrading the laboratories and in training young Nepalese clinicians and scientists. The main research focus is on the most common infectious diseases affecting the Nepalese population with a major focus on undifferentiated febrile illnesses and antimicrobial resistance.

Please see more information on OUCRU website: www.oucru.org

1.   Quality Management System Implementation:

• Lead, implement, and maintain GCLP and ISO 15189 standards at OUCRU Microbiology Lab and collaborating Hospital Laboratories. 
• Ensure full adherence to quality management systems in all laboratory units, maintaining accreditation compliance and promoting continuous enhancement of laboratory quality standards.

2.   Document Control:

• Supervise and manage the document control systems for laboratory operations, ensuring that all documents are accurately organized and regularly updated.
• Support and guide staff in drafting, revising, and maintaining comprehensive manuals, policies, SOPs, QA/QC records, and work instructions, ensuring compliance with accreditation requirements and best practices in documentation management.

3.   Equipment Management:

• Develop and maintain detailed equipment files, including documentation such as registration forms, calibration reports, installation qualifications, and maintenance logs.
• Assist in preparing annual maintenance contracts to ensure optimal equipment performance and service continuity.
• Monitor and perform routine quality assurance checks on daily equipment records to maintain compliance with operational standards.

4.   Training and Staff Development:

• Assist the Head of Laboratories in coordinating and delivering a variety of training sessions, including:
• Annual safety training to reinforce safe lab practices.
• Quality management and ISO-related training to ensure compliance with accreditation standards.
• Laboratory induction training for new staff to familiarize them with lab protocols, safety, and quality procedures.
• Collaborate with the Health and Safety team to organize and deliver training on risk management, compliance updates, and incident response procedures.
• Evaluate the effectiveness of training using feedback and performance indicators, and implement improvements as needed to ensure alignment with laboratory objectives and the ongoing development of staff skills.

5.   Laboratory Safety & Waste Management:

• Assist in the implementation of standards for safe collection, decontamination, and proper disposal of waste.
• Work alongside the Head of Laboratories to ensure the laboratory complies with all safety and waste management protocols.

6.   Routine Laboratory Audits:

• Assist in conducting routine audits of various lab areas (specimen reception, media preparation, sample management, Microbiology labs, Molecular labs etc.).
• Follow up on audit reports and ensure implementation of corrective actions as required.

Selection criteria

Essential: 

• Five years of  experience in laboratory work and two years of experience with Quality Management Systems (QMS), ISO Laboratory Accreditation (ISO 15189), and Good Clinical Laboratory Practices (GCLP)
• Master’s degree in Microbiology or a related field
• Document Control: Strong organizational and document control skills, with experience in maintaining accurate and accessible laboratory documentation.
• Technical Expertise: In-depth knowledge of laboratory quality management systems, including ISO 15189, GCLP, and WHO standards.