- Review existing laboratory quality

management processes (e.g., metrological

traceability, review of requests and contract

analysis) in collaboration with laboratory

management and staff and develop a gap

analysis report and action plan

- Meeting Notes/ Gap Analysis report and

action plan

- Develop/revise, and monitor the

implementation/execution of procedures,

SOPs and related forms (e.g., metrological

traceability, review of requests and contract

analysis), in collaboration with laboratory

management and staff, which align with the

requirements of ISO 17025 and WHO

Prequalification

- Finalized procedures (SOPs along with

forms)- 20+

- Actively support, provide recommendation

and follow up Corrective and Preventive

Action (CAPA) reports of

assessment/internal audit/mock audit to

improve the capabilities and readiness of

NHQC for on-site inspection of ISO 17025

accreditation and WHO PQ

- CAPA report or implementation plan towards

ISO 17025 accreditation and WHO PQ

- Deliver quality management and procedure

related trainings in partnership with the

regional technical consultant

- Training material and reports (estimated

about 1-6 trainings)

- Support the NHQC Quality Management

Systems activity, focusing on investigations,

corrective and preventive Actions (CAPAs),

Proficiency Testing, and Internal Auditing in

order to evaluate and trend the laboratory’s

progress toward ISO 17025 accreditation or

WHO prequalification.

- Internal/External Audit report, MR report, PT

report.

- Facilitate and convene meeting with NHQC

management, MOH and relevant

stakeholder to discuss and define the scope

of accreditation and initiate/prepare

documentation for the application process

of accreditation

- Minutes meeting and documents for

application of accreditation

- Administrative activities such as attending

regular technical team meetings and lab

POCs

- Monthly activity-based report to USP project

manager

 BS in Pharmacy, Chemistry, or related field with 5 years’ experience or in Quality

Control and Quality Assurance activities in the pharmaceutical industry or regulatory

environments.

 Minimum five years’ experience working in a pharmaceutical QC/QA Department or

equivalent

 3 to 5 years of experience in a structured quality system environment (such as

ISO/IEC 17025, ISO 9001, ICH, WHO Guideline GPPQCL TRS 957, auditing QC labs

or other)

 In depth knowledge of ISO/IEC 17025, ISO 9001, WHO Guideline GPPQCL TRS 957,

etc)

 Experience with developing Quality Management Systems for QC laboratories,

ISO/IEC 17025 requirements, SOPs, Quality Manual, etc.

 Experience and understanding of CAPA, complaint handling, nonconforming testing

work, document control, record control, good documentation practices, internal

auditing, and quality management system structure

 Has experience and knowledge on QC Laboratory is preferred.

 Experience with QMS and SOP auditing, monitoring, evaluation and follow up

 Prior experience working with Cambodian Government Officer preferred

 Effective communication skills as a team player, and experience with project

implementation at national and local levels.

 Solid skills in MS Word, MS Projects, Excel, and Powerpoint

 Proficiency in written and oral English is required

Period of Performance

 The period of performance will be from August 25, 2022 – December 31, 2023.

Please submit resumes (CVs) and an hourly rate by August 25 th to

GPH_Procurement@USP.org, with attention to Hana Keno, and with the following subject

header: Quality Management System (QMS) Consultant Opportunity for Cambodia