Pharmacist Assistant at Biovac

The Biovac Institute requires a fixed term Pharmacist Assistant: QA Release and Outsource to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub-Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services, and market diversification.

The successful incumbent will report to Senior QA Pharmacist

Job Purpose

• Responsible for QA Post Basic Pharmacist administrative 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 QA Pharmacist Assistant (Post Basic) 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

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.

Release Functions

• Review all manufacturing batch records and packing batch records
• Reviews autoclave charts, wash cycles, filter slips and vial wash cycles
• Assist Senior QA Pharmacist and participate in investigations in the event of medicine recalls and assist in retrieval of data.
• Adhere to Quality Standards to comply with SAHPRA and PIC/S guidelines with regards to for e.g.: Batch documentation auditing and control.
• Reviews the visual inspection batch records
• Review documents against cGMP standards and participate in auditing when required

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.

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 escalate 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:

• Good understanding and working knowledge of Quality Systems.
• Knowledge of pharmaceutical industry standards and guidelines in GMP and Quality
• Documentation Management
• Standard Operating Procedures
• cGMP knowledge
• Total Quality Management & Quality Management Systems
• Data development, trending & reporting

Generic Competencies required to perform this aspect of the role:

• Planning, Organizing, execution and monitoring
• Creative problem-solving skills 
• Internal stakeholder management
• Action & Results Oriented
• Assertive & Resilient
• Ability to multitask
• Influencing skills
• Proactive
• Clear, timely and effective communication skills both verbally and in writing

Experience & industry accreditation/ knowledge

Required:

• At least 8-9 years’ experience within the pharmaceutical/ vaccine or sterile manufacturing / quality assurance or similar position
• Experience in quality management systems within a cGMP facility
• Experience and understanding in aseptic (sterile) manufacturing
• Experience and understanding with vial packaging
• Experience and understanding with sterile formulation
• Experience and understanding with sterile filling
• Experience and understanding vial visual inspection
• Understanding and experience with reviewing of aseptic batch records (Charts/Cycles/Test slips)

Preferred:

• Knowledge of Pharmaceutical related legislation
• Experience in managing databases
• Previous participation in quality audits will be an advantage Matric/ Grade 12 or equivalent.
• Post Basic Pharmacist Assistant

Qualifications

Required:

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

Other Requirements

•      Own reliable transport