Release Pharmacist

3 weeks ago

Cape Town, South Africa Biovac Full time

**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**:

- Bachelor's degree in pharmacy or Diploma in Pharmacy.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 1-2 years experience in batch release for sterile manufacturing.
- Experience in quality and regulatory compliance within a cGMP facility.
- Experience in aseptic (sterile) manufacturing
- Technical report/process writing skills.
- Excellent communication skills and operational planning.
- Experience in having faced successfully local and/ or international quality audits.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:

- Review and approve 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 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.
- 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 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 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 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 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 by 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: 05 April 2023

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