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  • Posted: Oct 12, 2021
    Deadline: Oct 15, 2021
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    The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and th...
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    Sample Collector for Anti-malarial PMS Study

    Period of Performance: October 25 - 29, 2021 (One Week)

    Summary of the Position

    • Sample collectors as Mystery shoppers for first round of anti-malarial PMS study across eleven (12) PMI States.

    Role and Responsibilities

    • The sample collectors will act as Mystery shoppers on a covert mission to pick samples of antimalarial across three (3) senatorial districts across eleven states plus the FCT (12) PMI States (Akwa Ibom, Bauchi, Benue, Cross River, Ebonyi, Kebbi, Nasarawa, Plateau, Oyo, Sokoto, Zamfara and FCT).
    • Undergo virtual interview
    • Undergo virtual sample collectors training
    • Procure sample collection materials
    • Covertly sample antimalarial across three (3) senatorial districts
    • Document and tabulate sample details on sampling form and electronic forms
    • Label collected sample appropriately
    • Courier collected sample to PQM+ Abuja office
    • Manage funds for procurement, write expense reports and retire unused funds
    • Write a report on sample collection operations.

    Deliverables Expected:

    • Collect the required amount of antimalarial sample
    • Courier the collected sample to PQM+ Abuja office
    • Write expense report and retire unspent fund
    • Write report on Sampling
    • Submit all electronic records, hard copy forms and reports to team lead.

    Key Requirements

    • Discipline in Pharmacy or any of the Life Sciences background.
    • Preferably must be resident in the sampling state
    • Should be able to speak the local dialect fluently
    • Good understanding of the public and private drug outlet
    • Should be able to speak the local dialect fluently.

    Preferred Qualification Required:

    • Country the work is expected to be completely done is Nigeria

    Remuneration
    USP offers an impressive benefits and allowances package.

    go to method of application »

    Technical Officer, Chemistry, Manufacturing & Control (CMC)

    Summary of the Position

    • The Technical Officer, Chemistry and Manufacturing Control (CMC) will provide technical assistance to POM+ supported manufacturers to produce quality assured maternal newborn and child health (MNCH), nutrition and malaria medical products.
    • The candidate must have expert skills in pharmaceutical manufacturing, dossier evaluations / submission and facility inspection. Assessment for compliance to Good Manufacturing Practice (GMP).
    • S/he must understand the pharmaceutical development process from pre-clinical development through life cycle management.
    • She will provide technical assistance to MRA in aspects of dossier evaluation and inspection of facilities for compliance to GMP.
    • Have good understanding of pharmaceutical regulatory environment for pharmaceutical manufacturing.

    Roles and Responsibilities

    • Provides technical assistance to local manufacturer’s in-country to implement and comply with GMPs and in the development of dossiers to submit for WHO prequalification.
    • Facilitate the development of quality management documentation in compliance with WHO guidelines.
    • Build capacity on dossier compilation, GMP compliance, GxPs for staff and identified gaps in knowledge towards compliance on WHO guidelines,
    • Conduct mock GMP inspection(s) in preparation for WHO P0, MRA/Regional body/Multilateral procurement agency inspections as welt as effective implementation of CAPA plans.
    • Facilitate the development ol rn4ious training programs to ensure sustainability and knowledge transfer.
    • May provide mentorship to staff as applicable
    • Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports.

    Basic Qualifications

    • Minimum of 6+ years of experience leading and implementing technical assistance programs in expanding access to global health products and pharmaceuticals.
    • Bachelor's Degree in Pharmacy, Pharmaceutical Science Chemistry, Engineering, or Science related field of study required.
    • Working understanding of Chemistry, Manufacturing and Controls, good manufacturing practice, dossier evaluation and inspection.
    • Direct experience implementing USAlD4unded programs.
    • Direct experience and understanding of WHOP pre-qualification process.
    • Strong written (especially technical writing) and oral communication skills.
    • Experience working with regional regulatory bodies and/or local manufacturers.
    • Willingness to travel at least 25% of the time.

    Preferred Qualification Required:

    • Minimum of 3+ years of people managerial experience and skills
    • Experience in at least one of the following health areas: HIV/AIDS, Malaria, TB, NTDs, AMR, MNCH
    • Country the work is expected to be completed done: Nigeria.

    Restrictions or Key Requirements for The position:

    • Must be resident in Lagos
    • Should be able to speak the local dialect fluently.

    Remuneration
    USP offers an impressive benefits and allowances package.

    go to method of application »

    Technical Officer, QA / QC & RSS

    Summary of the Position

    • The Technical Officer, Quality Assurance / Quality Control (QA/QC) will provide technical assistance to the National Agency for Food and Drug Administration and Control (NAFDAC) network of laboratories to build their capacity to ensure the quality of medical products circulating in the Nigeria market.
    • They must possess a deep understanding of the pharmaceutical regulatory environment a low Income arid middle-income countries to provide technical oversight for strengthening the capacity of laboratories responsible for assessing the quality of medical products and vaccines.

    Role end Responsibilities

    • Facilitates 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 based on the findings of the WHO Global benchmark assessment related to laboratory testing
    • Leads the rollout of risk-based post marketing surveillance and the uptake and application of the MadRS tool
    • Provide technical assistance for ISO/IEC 17025:2017 accreditation and/or WHO prequalification by assessing, auditing, preparing and reviewing laboratory processes end procedures
    • Assist in preparation of quality control laboratories for WHO inspections, including assistance in strengthening GelS procedures to prepare for WHO Inspections, conducting of mock audits and preparation 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 steel regulatory trends and WHO guidance
    • Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports

    Basic Qualifications

    • Bachelor’s Degree in Pharmacy, Pharmaceutical Science, Chemistry, Engineering or Science related field of study required
    • Six (6) years of relative experience leading and providing technical assistance to quality control laboratories in medicine regulatory authorities (MRA5) 10 ensure the availability of quality medical products.
    • Direct experience Implementing USAID-funded programs.

    Skills Sought:

    • Bachelor’s Degree in Pharmacy, Pharmaceutical Science, Chemistry, Engineering or Science related field of study required
    • Working knowledge and understanding of regulatory systems strengthening In Nigeria with an emphasis on Quality Assurance/Quality Control of medical products
    • Strong written (especially technical writing) end oral communication skills
    • Willingness to travel at least 25% of the time.

    Preferred Qualification Required:

    • Two years people management experience and skills
    • Direct experience with and understanding of WHO global benchmarking tool
    • Experience in at least one of the following health areas: HIV/AIDS, Malaria, TB, NTDs, AMR, MNCH
    • Country the work is expected to be completed done: Nigeria.

    Restrictions or Key Requirements for the Position:

    • Must be resident in Abuja
    • Should be able to speak the local dialect fluently.

    Remuneration
    USP offers an impressive benefits and allowances package.

    Method of Application

    Interested and qualified candidates should send their CV to: GPHNigeriaRecruitment@USP.org using the Job Title as the subject of the email.

    Note

    • USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity orany other protected class.
    • We are committed to working with and providing reasonable accommodation to individuals with dieabilities.
    • USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. It is PQM+ intent to grant this offer to the most suitable candidate.

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