Responsible Pharmacist - Midrand
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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