Vacancy Announcement for QMS Internal Auditor Consultant MSH

Vacancy Announcement for Consultant Quality Management Systems Internal Auditor Training and Assist on Internal Quality Audit at DDA

Recruitment of a local consultant to conduct a Quality Management Systems Internal Auditor Training and assist on internal quality audit at DDA

About the job

Background

Department of Drug Administration (DDA) is the national medicines regulatory agency of Nepal established per the Drugs Act, 1978 and is one of the departments under the Ministry of Health and Population. The Act provides DDA a mandate to carry out its regulatory functions. The recent WHO Global Benchmarking Tool (GBT) assessment identified the maturity level of DDA as low. Several measures are needed to increase the regulatory maturity of the DDA and advance the government’s goals for the pharmaceutical sector, including the institutionalization of a Quality Management System as per ISO 9001: 2015, whose requirements are crosscutting to the GBT regulatory functions.

MTaPS is supporting DDA to increase its maturity level to 3 as per the WHO GBT. An action plan for years 2021‐2023 was drafted based on the DDA Business Plan 2019‐2020, WHO GBT assessment conducted in March 2021 and the accompanying Institutional Development Plan (IDP).

A functional QMS based on ISO 9001:2015 standard contributes to increase the capacity of DDA to provide pharmaceutical regulatory services that meet customer and applicable statutory and regulatory requirements with enhanced customer satisfaction. To date, MTaPS has supported DDA in conducting gap analysis, preparing roadmap to establish quality management system, establishing a technical working group (TWG), providing awareness training on QMS to its staff, trained members of the TWG on QMS through IRCA approved ISO 9001:2015 Lead Auditor Training, and established a documented information management system which included drafting a quality manual.

The objective of this consultancy is to provide Quality Management Systems Internal Auditor Training according to the ISO 9001:2015 standard for the Internal Quality Audit team of DDA and assist them to conduct an Internal Quality Audit at DDA.

Supervision and reporting responsibility:

The local consultant will be supervised by, and report to Samrat Baral, Technical Advisor at MTaPS Nepal in collaboration with Birna Trap, Country Program Director at MTaPS, Nepal. The local consultant will work in close coordination with the DDA. The local consultant will liaise with other members of the MTaPS team, DDA, MOHP and other key stakeholders.

Description of Services to be providedThe local consultant will undertake the following activities in collaboration with the DDA and MTaPS Nepal team:

Prepare training materials related to Quality Management Systems Internal Auditor Training (Based on ISO 9001:2015 Standard) with appropriate case studies. Prepare pre and post examination tests to assess the understanding of the trainees
Conduct Quality Management Systems Internal Auditor Training (ISO 9001:2015) to the Internal Quality Audit team of DDA and generate a training report
Assist the Internal Quality Audit Team of DDA to conduct internal quality audit at DDA to identify gaps in the QMS and at the same time guide the newly trained quality officers in practical application of the knowledge shared
Review Nonconformity Report (NCR)/Corrective and Preventive Actions (CAPA) report to ensure timely implementation

Deliverables or Milestones

Quality Management Systems Internal Auditor Training materials, pre and post examination tests documents, and training report
Internal quality audit report conducted along with the Internal Quality Audit Team at DDA
Revised Nonconformity Report (NCR)/Revised Corrective and Preventive Actions Report (CAPA)

Consultant qualification requirements:

Bachelor’s degree or equivalent in pharmacy, public health, medicine, business administration or related field
Certified Lead Auditor or Trainer; ISO 9001 – IRCA Approved
Minimum of five years of practical work experience as an ISO 9001 Consultant, Auditor and/or Trainer
Experience working with national medicine regulatory agencies, governmental agencies or USAID‐funded projects preferred
Prior experience providing technical assistance to or working directly with the DDA or government institutions
Good knowledge of Nepali legal framework and legislative process
Ability to design and conduct knowledge and skill-building training and workshops related to quality management system
Ability to plan and conduct the internal quality audit in an effective manner and prepare and review internal audit reports
Proven skills in preparing reports, technical documents, analysis, and presentations
Ability to organize the work with minimum supervision
Advance skills in Microsoft and Google suite of products
Excellent written and verbal communication skills in Nepali and English

MSH is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender or gender identity, religion, creed, citizenship, national origin, age, veteran status, or disability unrelated to job requirements. MSH will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, MSH has developed and maintains an affirmative action program and plan.

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