The Biovac Institute requires a PPM & Cold Room Co-coordinator for the Visual Inspection, Labelling and Packing Department (VLP) 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 VLP Supervisor.
The Key Performance Areas for this position include:
- Routine Activities
- Identify potential problem areas, ensuring early detection or diagnosis and implementation of solutions relating to inventory management.
- Ensure that all components required for daily running of VLP are adequately stocked according to the production plan at all times and are executed under the supervision of the Pharmacist and Supervisor.
- Ensure that waste disposal processes of product and components are strictly adhered to and documented.
- GMP Documentation
- Carries out responsibilities in accordance with the organization’s policies, industry standards and applicable laws.
- Regulatory and statutory requirements are met.
- Strict adherence to cGMP and current Good Warehouse Practices (cGWP)
- Competence and strict adherence to SOP instructions at all times.
- Maintains a healthy and safe work environment by implementing the requirements of the EHS principles.
- Adhere to Good Documentation Practices (GdocP).
- Adhere to and remain updated with required training at all times.
- Report any issues that might affect product quality timeously to VLP management.
- Assist with or lead investigations pertaining to deviations.
- Follows Standard Operating Procedures and manuals related to materials safety sheets, safety, packaging, cleaning, assembly and disassembly of machinery.
- Specific tasks
- Operate Pedestrian Controlled Stacker/s during daily production activities.
- Prepare the required process steps (materials, waste) and process space in time to ensure no loss in the planned production activities/schedules.
- 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.
- Receive and issue requested PPM components and product from Supply Chain and Packaging areas.
- Maintain batch integrity by allocating bin locations for storage of PPM and Product and record in log books accurately and timeously.
- Manage Material Transfer Airlock – PPM and other Rejects are disposed of as waste and all relevant documentation completed.
- Log and Secure rejected product storage and coordinate destruction of rejected product with the Supervisor and EHS Department.
- Completion of documentation and log book entries accurately and in real time.
- Prepare product for transfer to Supply Chain.
- Advise Team Leader, Supervisor or Section Head of any potential bottlenecks and or storage problems experienced with the operation of the PPM and Cold room
- Assists Administrator with requisition of goods required or to be delivered to or from Supply Chain.
- Maintain all equipment related paperwork and reports.
- Technical Responsibilities
- Write SOPs and Work Instructions according to the company’s templates and policies.
- Early detection or diagnose and troubleshooting of problems arising on the equipment or cold room to prevent downtime and component wastage.
- Engage with the Engineering Department and service providers to provide meaningful information and assistance on cold room maintenance, processes, DMS, machinery and improvements.
- Provide technical feedback and advice when necessary to Supervisor, Engineering or Service Providers if required
- Plan / Maintain and or Improve Cold room operation systems to ensure batch integrity at all times
Qualifications and Skills Required:
- Grade 12 with Learner Basic Pharmacist Assistant Qualification
- 2 – 3 Years experience in production warehouse environment in the pharmaceutical industry
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 www.biovac.co.za/register-apply-today by 07 August 2017.