Job Description

Job Summary Minimum Requirements: Essential: BPharm Qualification. Essential: Registered with The South African Pharmacy Council. At least 2 years of experience in Quality Assurance Management. Experience in submitting dossiers in the CTD (Common Technical Document) format. A minimum of 2 years of experience as a Responsible Pharmacist. In-depth knowledge of Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and Good Warehouse Practice (GWP) possessing a certificate would be beneficial. Minimum 2 years of experience in compiling and submitting Act 101 (SAHPRA) and Act 36 (DALRRD) dossiers. Possess previous experience in the Animal Health industry. Beneficial: Familiarity with regulatory submissions in Botswana, Namibia, Zambia, and Zimbabwe. Have knowledge of Pharmaceutical Production processes. Valid Drivers License and Vehicle. Duties and responsibilities: Prepare high-quality dossiers and submit them within specified timelines in designated countries to expedite registrations and approvals. Review, approve, and oversee the preparation of product labelling. Evaluate and approve product promotional materials. Manage local pharmacovigilance activities. Provide quality oversight for manufacturing, warehousing, and distribution operations. Conduct quality checks and release locally manufactured products (Act 36/1947) and imported products (Act 36/1947 and Act 101/1965). Develop and maintain quality documentation such as SOPs, Annual Product Reviews, and Batch Manufacturing Documents. Conduct self-inspections and manage external audits. Assist the QA Manager in complex and external audits when needed. Act as the Deputy Responsible Pharmacist for the entity. Implement regulatory strategies. Establish and maintain communication with regulatory agencies. Prepare and submit dossiers for regulatory approvals. Manage the maintenance and lifecycle of product dossiers. Oversee project management activities. Conduct regulatory due diligence for potential opportunities. Coordinate and oversee the management of local pharmacovigilance activities. Ensure compliance with appropriate quality requirements. Manage the Quality Management System (QMS) and related documentation. Provide training on quality activities. Manage audits and inspections to ensure compliance with regulations. Closing Date: Submissions for this vacancy will close on 4th August 2023, however, you will still have the opportunity to submit your CV for this position till 21st August 2023, Please Note: Thank you for submitting your CV to Marvel Placement Consultants. We value your submission, and we try our utmost best to get back to each applicant. However, should your application be successful, we will be in contact with you. Should you not hear from us within two weeks of application, please consider your application as unsuccessful. We are however recruitment specialists and will keep your details on our database for possible future opportunities. PoPI Act: Please note that Marvel Placement Consultants adhere to the POPI Act (Act No. 4 of 2013: Protection of Personal Information Act, 2013). Section 9 of PoPI states that "Personal Information may only be processed if, given the purpose for which it is processed, it is adequate, relevant and not excessive".

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