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    Responsible Pharmacist - Midrand, South Africa - Professional Resources Partners Pty Ltd

    Professional Resources Partners Pty Ltd
    Professional Resources Partners Pty Ltd Midrand, South Africa

    1 week ago

    Default job background
    Full time
    Description

    Summary of position:

    Regulatory:

    Responsible for:

    • preparation of good quality dossiers and submissions according to specified timelines, in designated countries, to ensure earliest registrations and approvals.
    • preparation, review and approval of product labelling.
    • review and approval of product promotional materials.
    • management of local pharmacovigilance activities

    Quality:

    Responsible for:

    • quality oversight of activities in a defined scope (manufacturing, warehousing and distribution.
    • QC checks and release of locally manufactured products (Act 36/1947) and imported products (Act 36/1947 and Act 101/1965).quality documentation e.g., SOPs, Annual Product Reviews and Batch Manufacturing Documents.
    • self-inspections and external audits
    • assisting QA Manager in complex and external audits as required

    Requirements:

    • Must have Matric / Grade 12
    • Pharm degree
    • Registered with The South African Pharmacy Council
    • Minimum 2 years Quality Assurance Management experience
    • Minimum 2 years' experience as a Responsible Pharmacist
    • Minimum 2 years' experience in compilation and submission of Act 101 (SAHPRA)and Act 36 (DALRRD) dossiers
    • CTD dossier format submission experience
    • Thorough understanding of GDP/GMP/GWP
    • MS Word, Excel and PowerPoint – intermediate to advanced skills required.
    • High accuracy and attention to detail skills
    • Strong work ethic

    The following would enhance your position:

    • GDP/GMP/GWP Training / Certificate
    • Animal Health industry experience
    • Knowledge of regulatory submissions in Botswana, Namibia, Zambia and Zimbabwe
    • Pharmaceutical Production knowledge.

    Main Accountabilities:

    Regulatory:

    • Act as Deputy Responsible Pharmacist for the entity.
    • Execute Regulatory Strategy
    • Agency contact
    • Preparation and submission of dossiers
    • Maintenance & Lifecycle Management of product dossiers
    • Project Management
    • Regulatory due diligence on potential opportunities
    • Management of local Pharmacovigilance activities

    Quality:

    • Operate at appropriate level of quality requirements.
    • QMS & Documentation
    • Conduct training on quality activities
    • Audits & inspections.
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