Website The Biovac Institute
The Biovac Institute requires a Production Leader 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 perform a support role within the Formulation and Filling section and assist the Section Head with the requirements for the management of both vial and prefilled syringes operations. The incumbent will also play a curtail role in the execution of Projects and Technology Transfers within the Production unit. The section is responsible for the formulation and fill of vaccines for human use at commercial scale.
The successful incumbent will report to the, Formulation & Fill Section Head.
Summary of role
- Shared accountability for achieving the site’s tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements.
- Identify and continuously present key opportunities and synergies that will improve and/ or expand the operation within own and/ or other sections.
- Lead or participate in section and/ or site wide projects.
- Monitoring & reporting on key operations, critical numbers and key performance indicators that impact the section’s short, medium and long term objectives.
- Participate with the section head, department manager and other senior and middle managers in proactively mitigating risks and find solutions where possible.
- Conduct effective and comprehensive costing, budgeting and expense management for own section, taking all overlapping site activities into consideration.
- Lead own section’s transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage and contributing to overall profitability.
- Manage internal customer relations and communication.
Core Technical Delivery
- Conduct section planning and execute activities within own scope of accountability.
- Monitors the sections Quality Objectives and ensures that the requirements are met.
- Collates data to trend operational output and efficiencies.
- Ensure that the day to day running of the Production facilities are executed according to the proper cGMP requirements.
- Ensure plant/ personnel hygiene and cleanliness is maintained within the formulation and filling floor.
- Monitor the status of plant/equipment maintenance and calibration.
- Ensure equipment qualification relevant to the section are completed and maintained through the life cycle of the section.
- Authorise documents owned by the section, e.g. written procedures, protocols, specifications for quality controlled goods, sampling instructions, test methods and data sheets, including amendments.
- Compilation of manufacturing documents and standard operating procedures for the formulation and filling of vaccines and other products.
- Ensure required initial and continuing training of section’s personnel is carried out and adapted according to need i.e. staff operating within the cleanroom must be adequately trained on aseptic technique and cleanroom behaviour.
- Initiate investigations for OOS or other investigations.
- Participation in the execution of Technology Transfers and other projects as a subject matter expert.
- Tracks the completion of Projects as per the agreed timelines and coordinates the execution of deliverables within the section.
KNOWLEDGE & CAPABILITY REQUIREMENTS TO SUCCEED IN THIS ROLE:
- Degree / Diploma in Biotechnology/Microbiology/Chemistry/Pharmacy or equivalent
- Recognition is given to Prior Learning and practical experience.
- 2 – 3 years’ experience in e.g. vaccine / biotech / pharmaceutical industry or equivalent.
- Management/supervisory experience in cGMP vaccine manufacturing / quality control or similar position.
- Quality and regulatory compliance knowledge, i.e. MCC and WHO would be an advantage.
- Sound technical ability in the field of manufacturing and support activities.
- Experience in having faced successfully local quality audits would be an advantage
- Experience in sterile manufacture and related aseptic techniques associated with the formulation and filling of pharmaceutical products.
Own reliable transport
Shift work that may include weekends
If you are interested in applying for this opportunity then kindly forward your application onto
email@example.com on or before 31 May 2018.
Biovac supports employment equity principles and for this reason, all vacancies are filled in accordance with our diversity management strategy and equity plans.
Please note that by submitting your application for this career opportunity you agree that Biovac may use your application for the purpose of our recruitment and selection process and where required, we may share your information with the relevant internal and external stakeholders involved in this process.