Technical Officer (PQMPlus, QA / QC & RSS) at US Pharmacopeial Convention (USP)

Job Category: Technical Programs

Description / Responsibilities

• Facilitate the development of in-house training programs to ensure sustainability and transfer of knowledge within NAFDAC laboratories.
• Advises on the interventions to address institutional development plans on the findings of WHO Global benchmarking assessment related to laboratory testing.
• Leads the roll-out of risk based post marketing surveillance and the uptake and application of the MedRS tool
• Provide technical assistance for ISO/IEC 17025:2017 accreditation and/or WHO prequalification by assessing, auditing in preparing and reviewing laboratory processes and procedures
• Assist in preparation of quality control laboratories for WHO inspections, Including assistance in strengthening QMS procedures to prepare for WHO inspections, conducting of mock audits and preparations of laboratory information files to be submitted to WHO.
• Assist laboratories during WHO inspections and in the development and implementation of CAPA plans
• Provide oversight of local partners and consultants involved in laboratory activities.
• Keep abreast of the latest regulatory trends and WHO guidance
• Actively contribute to annual programmatic and resource planning process and to the development of quality and annual reports.

Basic Qualifications

• Bachelor's Degree in Pharmacy, Pharmaceutical Science, Chemistry, Engineering or Science related field or study required.
• Required: Bachelor's or better in Chemistry.
• Six (6) years of relative experience leading and providing technical assistance to quality control laboratories in medicine regulatory authorities (MRAs) to ensure the availability of quality medical products.

Skills Sought:

• Direct experience implementing USAID-funded programs
• Working knowledge and understanding of regulatory systems strengthening in Nigeria with an emphasis on Quality Assurance/Quality Control of medical product.
• Strong written (especially technical writing) and oral communication skills
• Willingness to travel to least 25% of the time.

Preferred Qualifications:

• Two years people management experience and skills
• Direct experience with an understanding of WHO global benchmarking tool
• Experience in at least one of the following health areas: HIV/AIDS, Malaria, TB, NTDs, AMR, MNCH.

Behaviors:
Required:

• Leader: Inspires teammates to follow them
• Innovative: Consistently introduces new ideas and demonstrates original thinking
• Dedicated: Devoted to a task or purpose with loyalty or integrity
• Team Player: Works well as a member of a group
• Functional Expert: Considered a thought leader on a subject.

COVID Provisions

• As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

Benefits

• USP provides you with the benefits you need to protect yourself and your family today and tomorrow.
• From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.