Production Pharmacist at The Biovac Institute

The Role

The Biovac Institute requires a Production Pharmacist 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 the Manager: F&F

Summary of role:

Legal Requirements

• Accountable for the compliance to all relevant aspects outlined by the SA Pharmacy Act 53 of 1974 and its current amendments and the Medicines and Related Substances Control Act, No 101 of 1965 and its current amendments.
• Accountable for the execution or of all legal activities defined by the SA Pharmacy Act 53 of 1974 and its current amendments and the Medicines and Related Substances Control Act, No 101 of 1965 and its current amendments.
• Mentorship and tutorship of pharmaceutical staff where applicable

Quality Deliverables

• Responsible to ensure that all operational activities and stages comply with company procedures, policies and regulatory GMP requirements.
• Responsible for execution and management of batch related deviation processes within the department.
• Responsible for execution and management of internal and external audit findings within the departments.
• Responsible for a state of audit readiness within the department.
• Responsible for the review and approval of batch records and operational related documentation.
• Responsible for delivering batch records and related documentation at a pharmaceutical acceptable standard.
• Responsible to ensure that all critical stages for which they are involved with, are executed to according to the quality standards set by the company and regulatory guides.
• Responsible to be involved in all critical stages of operation, predefined and agreed upon with the Responsible Pharmacist and relevant Quality Assurance and Department Managers.
• Assists in the investigation of incidents that have resulted in non-conforming products, compliance failures or customer complaints.
• Assists with the creation and updating of SOP’s and Work Instructions on a continuous basis and ensure the operational activities comply with Standard Operating Procedures.
• Assists with the creation and updating of batch records on a continuous basis and ensure the operational activities comply with Standard Operating Procedures.
• Responsible for the development and execution of the departmental training programme(s).
• Responsible to lead Root Cause Analysis and Risk Assessment activities with the department.
• Assists in attainment of Quality targets set for the department.

Operational Deliverables

• Responsible for the timeously delivery of batch records to Quality Assurance.
• Responsible for the timeous execution of all activities defined by the SA Pharmacy Act 53 of 1974 and its current amendments and the Medicines and Related Substances Control Act, No 101 of 1965 and its current amendments.
• Responsible for the timeous execution of all critical activities, predefined and agreed upon with the Responsible Pharmacist, Quality Assurance and Production departments. This includes, but not limited to:

1. Independently checking and signing each dispensed material and its mass or volume
2. Checking and signing the addition of each material to the mix
3. Checking and signing the identity of the bulk product and printed packaging material
4. Checking and signing that each packaging line or station is clear of previous product, packaging components records, or materials not required for the planned packaging operations, and that equipment is clean and suitable for use before any packaging is undertaken
5. Other critical activities or stages as defined within each department as agreed upon the Responsible Pharmacist and relevant Quality Assurance and Department Manager.
6. The compounding, manipulation, preparation or packaging of any medicine or scheduled substance or the supervision thereof.
7. The manufacturing of any medicine or scheduled substance or the supervision thereof.
8. The purchasing, acquiring, importing, keeping, possessing, using, releasing, storage, packaging, repackaging, supplying or selling of any medicine or scheduled substance or the supervision thereof.

• Responsible for the management of pharmaceutical staff if applicable.
• Drives ‘first time right’ execution in all relevant activities.
• Assists in the attainment of Operational targets set for the department.
• Participate and delivers in Departmental projects.

Technical Competencies

• Excellent understanding and working knowledge of Quality Operations and systems.
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP and Quality Management.
• Documentation Management
• Environmental, Health & Safety Management
• Statistical Trending & Data Analysis
• Metric Development & Report Writing
• Coaching & Mentoring of peers & staff
• Review & Auditing Skills.
• cGMP vaccine manufacturing- quality and regulatory compliance & best practice knowledge e.g. PICs, SAHPRA requirements,
• Total Quality Management & Quality Management Systems
• Technical trending & report writing

Generic Competencies

• Planning, Organizing, Execution
• Creative Problem Solving & Innovation Skills
• Action & Results Oriented
• Assertive & Resilient
• Adaptable in Responding to change
• Negotiation and influencing skills
• Proactive in mitigating risk
• Clear, timely and effective communication skills both verbally and in writing
• Analytical Ability

Knowledge & Capabilities required to succeed in this role:

Qualifications

• B Pharm

Experience

Required:

• Completion of community service year

Preferred:

• At least 1 years’ operational experience in cGMP pharmaceutical manufacturing environment
• Experience in deviation, CAPA and change control management.
• Experience in GMP documentation aspects.
• Experience in aseptic (sterile) operations.
• Experience in vaccine manufacturing, visual inspection, labelling and/or packaging
• Experience in having faced successful local and/ or international quality audits.

Other Requirements

• Registered with the South African Pharmacy Council
• After hours availability, reliable transport, ability to travel nationally and internationally.