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    Document Reviewer - Durban, South Africa - Jobking

    Jobking
    Jobking Durban, South Africa

    3 days ago

    Default job background
    Full time
    Description
    Job Description

    • Ensure compliance with statutory requirements and requirements of Good Manufacturing Practice and cGMP in all activities and specifically in the generation of and review/audit of BMR/BPR's.
    • Compliance to the SA OHS (Act) /Health, Safety and Environment policy of the organization.
    • Generation of new BMR/BPR and related protocols/documents, as well as update of BMR/BPR and related documents via the Change Control Process
    • Monitoring of shop-floor (Manufacturing/Packing/Stores/QC) activities and review of related documents/ on-line BMR/BPR auditing
    • Auditing of batch records in accordance with Company SOP to ensure data integrity, compliance with cGMP and Regulatory requirements.
    • Follow up on BMR/BPR query and close out with relevant level
    • Review/ auditing of production shop-floor activities to ensure compliance to cGMP and regulatory requirements.
    • Administrative activities to support release plan such as H1 update, Syspro tasks,
    • To review the following documents and ensure compliance to prepare for QA Final Batch Release
    a. In-process data
    b. Bulk reconciliation data
    c. Product yield data
    d. Manufacturing and Packaging Job Record check lists
    e. Job Clearance information
    f. Non-conformance records
    g. Syspro printouts

    • Receiving and logging of documents for auditing
    • Control and Tracking of documentation
    • Conduct BMR/BPR auditing to a Not Less Than 95% Right First-Time level, prior to QA Log-in
    • Preparation of Protocols and maintenance of log books
    • Requisition and collation of additional release documents as and when required
    • Co-ordinate the Production Sample log-in to QC Laboratory
    • Trending of BMR/BPR errors and planning of relevant Corrective and Preventative actions to prevent repeat errors
    • Training on relevant SOP's and Documents
    • Follow instructions/activities as delegated
    Requirements, Qualifications & Experience
    Matriculation with a pass in Mathematics and English
    Basic/Post Basic Pharmacist Assistant (advantageous)

    Minimum 3 years experience in a Pharmaceutical manufacturing environment
    Experience in Document Auditing of BMR/BPR
    GMP knowledge and experience
    Computer Literacy and skills

    Duties & Responsibilities
    Refer to job description

    Apply Here
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