Production Assistant at The Biovac Institute

Summary of role

• Responsible to ensure one’s own safety is priority during any of the operational duties
• Responsible to identify safety hazards and improvements within the respective department.
• Responsible to promote the safety metrics as set forth by the Company
• Responsible to ensure that all production activities and stages comply with company procedures, policies and regulatory GMP requirements.
• Ensure the manufacturing and production activities comply with Standard Operating Procedures.
• Responsible for the housekeeping in the areas of expertise.
• Assists with the on-barding and induction training of new operational staff within the areas of expertise.
• Responsible for the escalation of any quality incidents during any production/operational activity
• Responsible for the execution of any relevant, trained task prescribed by SOPs or by the relevant Supervisors
• Responsible to timeously execute reasonable tasks as outlined by the production/operation supervisors, this includes but is not limited to:

1. Washing, preparation and sterilisation equipment
2. Scales, balances and in-process control equipment
3. Environmental and Utility sampling
4. Storage and management of cleaning material
5. Execution of waste removal
6. Preparation of gowning material.
7. Printing or completion of relevant labels
8. Manual packaging of products
9. Manual viewing of filled or semi-finished units for quality and aesthetic defects

Technical Competencies

• Knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Laboratory Management Technical Report writing
• Standard Operating Procedures
• Current GMP knowledge and understanding
• Technical machinery knowledge
• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. SAHPRA and WHO
• Quality management Systems

Generic Competencies

• Creative Problem Solving & Innovation Skills
• Adaptable in Responding to change
• Clear, timely and effective communication skills both verbally and in writing

Knowledge & Capabilities required to succeed in this role

Qualifications

Required

• Grade 12/ Senior Certificate
• Recognition is given to Prior Learning and practical experience.

Experience

• At least 6 months in a similar or relevant work environment
• Knowledge and experience in general hygiene
• Experience in documentation preparation

Preferred:

• Experience within a manufacturing/operations department
• Experience within a cGMP environment
• Gowning and cleanroom experience/knowledge

Other Requirements

• Potential shift work, reliable transport, ability to conduct road and air travel.
• Working within a cleanroom environment while being fully suited
• High levels of concentration
• Ability to perform repetitive tasks
• Eyesight testing
• Material lifting equipment licensing
• Visual inspection qualification programs.

All positions will be filled in accordance with our Employment Equity policy as Biovac is committed to the pursuit of excellence, diversity and redress.