Release Pharmacist - Cape Town City Centre
Biovac
BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Release Pharmacist to join a goal-oriented team. QUALIFICATIONS NEEDED: Degree in Pharmacy. NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE: At least 2-5 years of experience in manufacturing, with 2 years in sterile manufacturing. At least 2-3 years of experience in batch release for sterile manufactured products. Experience in quality and regulatory compliance within a cGMP facility. Technical report/process writing skills. Microsoft Office and Excellent communication skills. Operational planning. KEY DUTIES & RESPONSIBILITIES OF THE ROLE: Release Functions Review and approval of all manufacturing batch records for all various production departments within the defined timelines. Review and approval of QC documents required to adhere to guidelines for batch release within the defined timelines. Approval and final release of manufacturing products to the market and/or a third party as applicable within the defined timelines. Responsible for the release of products; and those products are released in accordance with appropriate marketing authorization following full batch and testing record review. Ensure the timeous completion and upload of the Lot Release applications and be responsible for steering the process till completion. Evaluate and authorize reprocessing of products or materials. Ensure that products are released in accordance with appropriate marketing authorization following full batch and testing record review. Assist the Release Manager and Head of Pharmaceutical Services/RP and participate in investigations in the event of medicine recalls and compile relevant reports. Adhere to Quality Standards to comply with SAHPRA, PIC/S, and WHO guidelines concerning for e.g. Batch documentation auditing and control, Finished product release, and Quality of products out in the market. Responsible for handling scheduled substances in a pharmacy. Legal requirements regarding the documentation and control of scheduled medicines should be adhered to. Responsible for handling product quality complaints Respond and manage quality reviews of adverse drug reactions post immunization and participate in investigations with the pharmacovigilance officer. Responsible for the compilation and review of Annual Product Quality Reviews Assist the Release manager to ensure that Annual reports are completed for the department where required. Communicate any delays in advance in terms of Batch release not adhering to specified timelines. Provide support and be available to the production departments. Ensuring that the department is audit-ready through closing out audit findings timeously. Ensure Deviations, Change Controls, and CAPAs are handled effectively. Assist the Release Manager in the management of the process of Advertising medicines. Data development, trending & reporting. Application Deadline: 31 March 2024 Disclaimer: Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application. For detailed information on data handling, please review our privacy notice: https://www.biovac.co.za/wp-content/uploads/2022/08/published_Biovac-Privacy-Notice-20220617-2306-en.pdf .
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