QA Release Pharmacist at Biovac

Cape Town, Western Cape, South Africa -

Full Time

Start Date

Immediate

Expiry Date

17 Jun, 26

Salary

0.0

Posted On

19 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Batch Release, Sterile Manufacturing, cGMP Compliance, Quality Assurance, Regulatory Compliance, Technical Report Writing, Process Writing, Microsoft Office, Communication, Operational Planning, Batch Record Review, Product Release, Reprocessing Authorization, Pharmacovigilance, Annual Product Quality Reviews

Industry

Pharmaceutical Manufacturing

Description

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 Quality Assurance Release Pharmacist to join a goal-oriented team. QUALIFICATIONS NEEDED: BPharm Degree At least 1-2 years' experience within the sterile pharmaceutical /API manufacturing industry. NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE: At least 2-3 batch release for sterile manufacturing. Experience in quality and regulatory compliance within a cGMP facility. Experience in manufacturing. Technical report / process writing skills. Microsoft Office. Excellent communication skills. Operational planning. KEY DUTIES & RESPONSIBILITIES OF THE ROLE: Core Technical Delivery 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 adherence of guideline for batch release within the defined timelines. Responsible for finished product batch release. Approval and final release of manufacturing products to the market and/or third party as applicable within the defined timelines. Responsible for the release of final 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 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 QA Release and Outsource Manager, Head of Quality and RP and participate in investigations in the event of medicine recalls and compile relevant reports. Adhere to Quality Standards in order to comply with SAHPRA and PIC/S guidelines with regards to for e.g.: Batch documentation auditing and control. Finished product release. Quality of products out in the market. Responsible for the handling of 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 to 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 QA Release and Outsource 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. Internal Application Deadline: 22 March 2026 External Application Deadline: 25 March 2026 If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful. We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity. 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.''

Responsibilities

The core technical delivery involves the review and approval of all manufacturing batch records and QC documents to ensure adherence to guidelines for timely batch release. This role is responsible for the final approval and release of manufactured products to the market in accordance with marketing authorization.