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  • Posted: Feb 21, 2020
    Deadline: Mar 1, 2020
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  • StreSERT is a professional services organisation that offers quality stress-free solutions to corporate organisations. We offer business support and integrated solutions in different areas that ensure business objectives are achieved. Critically, we evaluate issues as they impact your business, and consequently deploy the appropriate skills and competenci...
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    Regulatory Affairs Specialist (Sub Saharan Africa)

    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 ‘recruitment@stresertservices.com’ 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

    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 ‘outsourcing@stresert.com’ using “IPQA” as subject of the mail.

    Method of Application

    Use the emails(s) below to apply

     

  • Send your application

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