Website The Biovac Institute
The Biovac Institute requires a Cold Room Co Ordinator 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 Team Leader
Key Duties & Responsibilities
- Manage the administration, acquisition of and return or rejection of product to the cold room and PPM components from the PPM store and/ or warehouse and material airlock.
- Secure, utilise and orderly coordinate available space.
- Recording of applicable documentation and log books according to cGDocP.
- Ensure compliance in accordance with (Medicines and Related Substances Act 101 of 1965,
- Continuously support and prescribe to cGMP within Biovac.
- Ensure all components necessary for daily running of VLP are adequately stocked according to the production plan at all times.
- Non-wastage of materials and components by ensuring that waste disposal processes of product and components are strictly adhered to and reported.
- Operate Pedestrian Controlled Stacker(s) during daily production activities.
- Prepare the required process steps (materials, waste) and process space timeously (all processes and documentation).
- Completion of documentation and log book entries according to SOP and GdocP.
- Prepare product for transfer to Supply Chain.
- Daily monitoring and recording to DMS temperature, humidity and pressure differentials.
- Initiation of job card requests and assist or lead with investigations during breakdowns and/or deviations.
- Maintain all equipment related paperwork and reports.
- Standard Operating Procedure writing and assisting when required.
- Engage with the Engineering Department and service providers to provide meaningful information and assistance on cold room maintenance, processes, DMS, machinery and improvements.
- Plan/ maintain and or improve cold room operation systems to ensure batch integrity at all times.
Technical Competencies required to perform this aspect of the role:
- Knowledge of pharmaceutical industry standards and guidelines in GMP and Quality Systems.
- Standard Operating Procedures.
- Current GMP knowledge and understanding.
- Technical machinery knowledge.
- Knowledge of Quality Management Systems.
- Basic Technical Writing.
- cGMP knowledge
- Total Quality Management & Quality Management Systems
- Data development, trending & reporting
Generic Competencies required
- Planning, Organizing, Execution
- Creative Problem Solving & Innovation Skills
- Sustainable Stakeholder Management
- Action & Results Oriented
- Adaptable in Responding to change
- Proactive in mitigating risk
- Clear, timely and effective communication skills both verbally and in writing
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.
Knowledge & Experience
- Minimum 2 – 3 years’ experience in production warehouse environment in the Pharmaceutical industry.
- Knowledge of a sterile manufacturing of Pharmaceutical environment.
- F6A license- Bendi pedestrian- controlled stacker.
- Knowledge of Pharmaceutical related legislation
- Experience in having faced successfully local and/ or international quality audits.
- Grade 12/ Matric.
- Learner Basic Pharmacist Assistant Qualification.
Recognition is given to Prior Learning and practical experience.
Potential shift work, own reliable transport, ability to conduct road and air travel nationally and internationally
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress.
Interested persons to kindly submit their CV’s to firstname.lastname@example.org by 24 May 2018
Kindly note that by submitting your application for this career opportunity you agree that Biovac may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business