QA Pharmacist Assistant X2

2 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 QA Pharmacist Assistant to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Matric/ Grade 12 or equivalent.
- Post Basic Pharmacist Assistant.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 2-3 years of experience within the pharmaceutical/ vaccine or sterile manufacturing/quality assurance or similar position.
- Experience in quality management systems within a cGMP facility.
- Experience in managing databases.
- Previous participation in quality audits will be an advantage.
- Experience in aseptic (sterile) manufacturing.

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

- Deviation and Corrective Action Processes by promoting a culture of immediate reporting and ensuring that Deviations are tracked on all affected batch and testing records.
- Regulatory and Customer Audits: assist in audits, track completion, and close out of findings for the release section.
- Review documents against cGMP standards and participate in auditing when required.

**Release Functions**:

- Review all manufacturing batch records and packing batch records and associated documents.
- Assist Senior QA Pharmacist and participate in investigations in the event of medicine recalls and assist in the retrieval of data.
- Performs quality reviews on batch records.
- Adhere to Quality Standards to comply with SAHPRA and PIC/S guidelines with regards to e.g.: Batch documentation auditing and control.
- Assists with PQR compilation.

**Outsource**:

- Participate in writing and updating SOPs where required.
- Assists in ensuring that all current master documents which include but are not limited to specifications, and batch records are available and maintained as per SOP.
- Assists with adherence to export requirements.

**Routine Activities**:

- Document Administration for Release documents.
- Record Administration, archiving, and filing of documents product release documents.
- Batch book Issuing and retrieval.
- Database management and Report generation: for product release.
- General Administration including filing (electronically and hard copies), scanning, assisting in audits, etc.
- Measurement, Analysis, and Improvement Initiatives: Data capture, analysis, and assist in cross-functional projects.

**Application Deadline: 15 August 2023**

**_Disclaimer: _**
- By submitting your CV and personal information, you agree that Biovac may utilise this information to conduct and complete our recruitment process, which entails distributing your information to all internal recruitment participants and service providers who forms part of the process._

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