Job Opportunities at StreSERT Services Limited

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    • Contents
    • Open Jobs
      1. Regulatory Affairs Specialist (Sub Saharan Africa)
      2. In-Process Checker
    • Method of Application

    Regulatory Affairs Specialist (Sub Saharan Africa)

    • Job Type Contract , Full Time
    • Qualification BA/BSc/HND
    • Experience 4 – 5 years
    • Location Lagos
    • Job Field Pharmaceutical&nbsp

    Our client is a multinational Pharmaceutical organization. They seek the services of a Regulatory Affairs Specialist for a 2 years contract engagement.

    Department: RA (Global Drugs Development) GDD

    Reports to:  RA Head

     – 2 YEARS CONTRACT

    Job Purpose

    • Support the region (Sub Saharan Africa – SSA) with lifecycle maintenance activities
    • Coordinate submission of post-approval changes including variations and renewals for the region (SSA)
    • Coordinate update of (Chemistry Manufacturing & Controls – CMC) database when there are changes in country regulations and/or requirements
    • Maintain all necessary databases (e.g. DRAGON) to ensure regulatory compliance at all time.
    • Maintain open communication with the different stakeholders and regularly provide information when required.

    Major Accountabilities

    • Ensure the RA CMC database for the different countries in the region is up to date
    • Evaluate post-approval changes for impact on product supply and communicate to stakeholders accordingly
    • Ensure submission of post-approval changes such as production transfers, MAT and pack size extension are done on-time and approvals received early enough to ensure smooth implementation
    • Ensure that submissions for license renewal are done in good time before license expiry so as to achieve early approval
    • Support the update local/Regional Working Practices or SOPs when required.
    • Ensure adherence to Global and local/regional processes.
    • Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary
    • Ensure compliance to global and local KPIs.
    • Develop and maintain good working relationships with other company functions/departments both locally and globally, as well as with health authorities as required

    Key Performance Indicators

    • Ensure compliance with relevant Health Authority guidelines and regulations
    • Ensure all post-approval changes are submitted on time and follow up for approval
    • Meet product re-registration due dates and escalate possible adverse impact due to loss of license accordingly
    • Accurate maintenance of relevant regulatory information management system
    • Achieve Regulatory compliance deliverables as per global targets
    • Address issues related to compliance with urgency with escalations as appropriate
    • Share emerging regulatory intelligence with RA Heads

    ROLE PROFILE

    Education:          B. Pharm             

    Languages:         Fluent in English (mandatory)

    Experience:        At least 4-5 years RA experience

    • Good communication and negotiation skills
    • Good knowledge of CTD dossier format
    • Detail-oriented and organized
    • Good inter-personal skills

    Application:

    Candidates with a similar background who do not hold permanent employment should forward CVs to ‘[email protected]’ using ‘RAS-2YR’ as the subject of mail before 1st March, 2020. Applicants without the aforementioned background and experience need not apply.

    go to method of application »

    In-Process Checker

    • Job Type Full Time
    • Qualification BA/BSc/HND
    • Experience 1 year
    • Location Lagos , Ogun
    • Job Field Manufacturing&nbsp

    Location: Ikorodu, Lagos State & Ota, Ogun State

    JOB SUMMARY

    As an In-Process Checker, you are responsible to monitor all areas of production inspection process, including in-process Quality Assurance, incoming raw materials, and expiration dates. Review batch records of additives for accuracy and completeness for product disposition.
    RESPONSIBILITIES  

    • Issuance of Line Clearance
    • Monitoring GMP compliance
    • Filling of production logbook
    • Sampling of products and raw materials
    • Carrying out various quality test in the lab
    • Monitoring production process and compliance
    • All other instruction given by the line manager and other superiors

    JOB QUALIFICTIONS/REQUIREMENTS 

    • At least 1 year of experience directly related to the duties and responsibilities specified.
    • Bsc/HND in Natural Sciences Computer literate

    Salary

    Net Pay – N50, 000

    Application Closing Date
    28th February, 2020.

    How to Apply

    Applicants who meet the requirements listed above should forward CVs to ‘[email protected]’ using “IPQA” as subject of the mail.

    Method of Application

    Use the emails(s) below to apply

     

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