QA Pharmacist Assistant - Talent Pipeline

Biovac; Cape Town; On-site; ZAR 300,000 - 420,000; Full time

Job summary

Biovac is seeking a QA Pharmacist Assistant to support quality assurance activities in a cGMP environment. You will handle document administration for release, review batch records, and assist with QA release processes and audits at our facility in Cape Town.

Minimum qualification includes Post Basic Pharmacist Assistant with 2–3 years in pharma quality or sterile manufacturing. Knowledge of SAHPRA guidelines and regulatory compliance is essential.

Qualifications

• At least 2–3 years’ experience in pharmaceutical / vaccine or sterile manufacturing / quality assurance.
• Experience in quality management systems within a cGMP facility.
• Knowledge of pharmaceutical legislation is preferred.
• Experience in aseptic (sterile) manufacturing is a plus.

Responsibilities

• Document Administration for Release documents.
• Record Administration, archiving, and filing of release documents.
• Batch book issuing and retrieval.
• Data base management and report generation for product release.
• General Administration including filing, scanning, and audits support.
• Measurement, analysis and improvement initiatives and cross‑functional projects.

Skills

Quality Systems

GMP Knowledge

Documentation Management

SOPs

Education

Matric / Grade 12 or equivalent

Post Basic Pharmacist Assistant

Tools

Database management

Job description

Job Purpose

• Responsible for QA Pharmacist Assistant activities including but not limited to:
• To provide administrative assistance and support related to the Quality Assurance Systems.

areas.

• Participation in quality audits and support to teams.
• Effective implementation / maintenance of quality systems & safety systems.
• Ensure compliance with the Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974 and the organization’s policies, procedures and other applicable laws.

• Ensure review of batch records.
• Responsible to deliver release services and solutions in alignment with pharmaceutical quality system requirements.

• Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.

Minimum qualification(s)

Required

• Matric / Grade 12 or equivalent
• Post Basic Pharmacist Assistant

Experience & Industry Knowledge

Required

• At least 2-3 years’ experience within the pharmaceutical / vaccine or sterile manufacturing / quality assurance or similar position
• Experience in quality management systems within a cGMP facility

Preferred

• Knowledge of Pharmaceutical related legislation
• Experience in managing databases
• Previous participation in quality audits will be an advantage
• Experience in aseptic (sterile) manufacturing

Key Duties & Responsibilities

Routine Activities

• Document Administration for Release documents.
• Record Administration, archiving, and filing of documents product release documents.
• Batch book Issuing and retrieval.
• Data base 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.

Core Technical Delivery

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.
• Establish and apply continuous improvement processes.
• Regulatory and Customer Audits: assist in audits, track completion, and close out of findings for 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 QA Release and Outsource Manager and RP and participate in investigations in the event of medicine recalls and assist in retrieval of data.
• Performs quality reviews on batch records.
• Adhere to Quality Standards to comply with SAHPRA and PIC/S guidelines with regards to for e.g.: Batch documentation auditing and control.
• Assists with PQR compilation.
• Review and sign off QC packs
• Review and sign off temperature data packs
• Review retention samples
• Compilation of Lot Release documents
• Assist with raising and drafting responses for Inquiries
• Compilation of COA’s and LSP’s
• BOM compilation
• Assist with activities associated with the QA Release and Outsource Department

Outsource

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

Technical Competencies required to perform this aspect of the role

• Good understanding and working knowledge of Quality Systems.
• Knowledge of pharmaceutical industry standards and guidelines in GMP and Quality
• Documentation Management
• Standard Operating Procedures

Supporting Quality Management

• Building own cGMP knowledge and compliance
• Participate in achieving the company’s quality objectives.
• Participate in building a sustainable quality culture on site and proactive mitigate risks that may negatively impact quality or allocate these appropriately.
• Ensuring audit readiness within own role through closing out audit findings timeously
• Ensure Deviations, Change Controls, CAPAs are handled effectively
• Advocate continuous improvement

Technical Competencies required to perform this aspect of the role

• cGMP knowledge
• Total Quality Management & Quality Management Systems
• Data development, trending & reporting

Application closing date

22nd March 2027

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.