Production Administrator at The Biovac Institute

Job description

The Biovac Institute requires a Production Administrator 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 Section Head: Formulation and Filling  

The Key Performance Areas for this position include:

• Printing of all production logs on a monthly basis and management of the log book production register.
• Coordination of all production logs with production supervisors to ensure that logs are closed and archived on a monthly basis.
• Request of log book numbers.
• Control of the issuing and retrieval of production logs.
• Printing of all daily production documentation required for the cleanroom and related production areas i.e. labels and data sheets.
• Management of cleanroom data i.e. equipment batch reports.
• Control of SOP files in production and management of the issue and return of documents from the files.
• Coordination of expired or soon to be expired SOPs with the relevant production supervisor and/or specialist.
• Management and distribution of all production documentation i.e. SOP files.
• Updating of documentation such as SOPs and WIs where required.
• Consultation with the production plan, supervisor, section head and/or pharmacist for the planning and request of material and documentation for batches.
• Request of MBRs from Supply Chain and the coordination of the material request and delivery.
• Coordination of the receipt of material with the production pharmacist and transfer into the production area.
• Batch initiation by compiling all batch and preparation related documentation packs on time.
• Ensuring that batch documentation is arranged according to the correct quality standards.
• Completion of batch and preparation records within 2 days of batch completion. Ensuring that batch and preparation books are received from the supervisor after batch completion so that collation can start.
• Management of the batch book production register and ensuring that is always in an up to date state.
• Coordinating the batch and preparation books between the Production Pharmacist, Planning, Quality Assurance and Production.
• Completion and submission of all transport requests related to overtime work.
• Perform Navision orders with good timing and keep track of status of items at all times. Ensure Navision orders are tracked to completion (delivery).
• Perform all stationery requests for the department
• Management of the control room to ensure that it is used according to the correct guidelines.
• Regular monitoring of the control room during batch related activities.
• Coordination of expiring documents to ensure that nothing expires and that action is taken in time.
• Execution of CAPAs, CCNs and DRs according to the correct quality and timelines.
• Participation in audits.
• Ensuring that all equipment is in a state of compliance in terms of calibration, maintenance and qualification.
• Ensuring that all critical systems in production are trended and that trending spread sheets are up to date.
• Management of batch history in terms of trending to ensure that all criteria are captured on the appropriate spread sheet.
• Production Control Room:
• Management of the control room to ensure that it is used according to the correct guidelines.
• Regular monitoring of the PMS, DMS and CCTV system.
• Performing investigations related to control room/monitoring system
• Stock Control:
• Management of stock control initiatives for raw materials, components, filled product and formulated product (including samples retained in the production facility).
• Management the handover of filled product to the next processing department and adjustment of the stock control log book.
• Coordination of reconciliation of filled and formulated product and ensuring that stock control sheets have been completed.

Co Qualifications

Grade 12 with Learner Basic Pharmacist Assistant Qualification

Knowledge & Experience

• Knowledge of a sterile manufacturing environment
• Experience in documentation preparations, filing and other related administrative functions
• 1 years’ experience in vaccine / biotech / pharmaceutical industry or equivalent would be advantageous.
• Experience in cGMP vaccine manufacturing. Quality and regulatory compliance knowledge, i.e. MCC and WHO.

Other requirements

• Shift working
• Working within a cleanroom environment while wearing a cleanroom suite