Production Administrator at National Bioproducts Institute

National Bioproducts Institute NPC has a vacancy for the role of Production Administrator. The successful incumbent will be required to:

• To manage and control the inflow, outflow and maintenance of all controlled documents required in the department.
• To maintain department stats, compile reports and perform the required SAP transactions to ensure the efficient operation of the department.
• To ensure administrative support to department staff and all stakeholders within the organisation
• To ensure statistics required by stakeholders are available
• To ensure stock availability by placing requisitions and follow through until received
• To track and report batch status to ensure facilitation of operations
• Compilation of batch documentation for pharmacist review
• Auditing of batch documentation for Pharmacist review
• Confirmation and Goods Receipt of product yields on SAP for Pharmacist verification

Applications are invited from suitably qualified and experienced candidates.

Minimum Requirements    

• Relevant Tertiary Qualifications
• Exposure to SAP or other Electronic control systems
• Proficiency in Microsoft Word and Excel
• 2 years’ experience in a similar role within the pharmaceutical environment, with a firm understanding of cGMP and GDP

Duties & Responsibilities    
Control of MCDs

• Verification of MCD’s and collection from QA.
• Ensure correct filing of MCDs as per status of the batch in a timeous manner
• Compilation and review of MCDs to ensure completion
• Confirmation and Goods Receipt of product yields on SAP for Pharmacist verification
• Pre-audit of MCD as per checklist prior to pharmacist audit.
• Check that all calculations and formulations in the document are correct before pharmacist audit
• Submission of MCDs to ORP following pharmacist audit. Compilation of the final batch document to include all the reports and results of QC testing.
• Recording status of MCDs in log books when submitted to ORP. Ensure MCDs are received and acknowledgement of receipt completed on log book. Management of the Document Tracing Register for accuracy to ensure traceability
• Recording/tracking of MCD status until submission to ORP
• In-process monitoring of the batch documentation to ensure that all mandatory information is completed and verified.
• Follow up on MCD status for any queries where necessary
• Action all document queries to the relevant pharmacists, section heads and technicians
• Attend to MCD queries where possible.
• Maintain document release target of two weeks from production to ORP.
• Compilation of in-process data controls for product investigations

Control of departmental SOPs

• Maintenance of departmental SOPs by ensuring that SOP files and indexes are kept up to date with current versions at all times
• Assist in compilation of department MCD’s, PCD’s and SOP’s for implementation
• Assist with training of SOP’s and uploading of training records on SAP DMS
• Control of authorised copies of master document SOPs required for reference at the work stations
• Audit departmental document files periodically and maintain and manage the document system.
• Monitor status of documents under review periodically and follow up with relevant production personnel for completion of tasks
• Pre-audit of batch documents upon collection from QA and sign for accepting responsibility that the correct documents are ready for production

Control of departmental log books

• Control of all departmental log books and registers
• Compilation of departmental log books.
• Audit completed logbooks and submit to QA for archiving
• Request new log books in a timeous manner and ensure log books are available for use on time

Control of batch related information records

• Generation of equipment/machine reports and charts
• Pre-Auditing of batch reports and charts for accuracy
• Printing of reports and charts
• Attachment of reports and charts to the correct documents.
• Recording of batch information on reports and charts
• Ensure reports and charts are approved and authorised by pharmacist prior to attachment to relevant MCD
• Monitor status of documents under review periodically and follow up with relevant production personnel for completion of tasks

Data capturing and compilation of reports Monitor the assigned departmental stock requirements and levels.

• Update of daily departmental statistics in a timeous manner
• Compilation and Submission of the Monthly and Quarterly Process Control Review reports
• Compilation of in-process data controls for product investigations
• Highlighting and escalating discrepancies and trends observed
• Generation and printing of required reports from SAP
• Compilation of Employee Overtime Reports
• Assist in closing of departmental Notifications by printing SAP reports , to ensure that all outstanding notifications have been completed
• Assisting with updating the skills matrix template

Inventory management and procurement services

• Monitor the assigned departmental stock requirements and levels.
• Manage department stock takes to ensure reconciliation of stock
• Conduct weekly on-hand stock verification against SAP to ensure that the department stocks are up to date prior to periodic stock takes
• Create requisitions and reservations on SAP to order all departmental stock in a timeous manner.
• Tracking of all departmental non-stock items through procurement to ensure timeous receipt
• Follow up with warehouse and procurement personnel regarding status of requisitions placed

Plant maintenance co-ordination and admin support

• Process plant maintenance notifications on SAP and liaise with Engineering Services.
• Attend the weekly Compliance Meetings with QA to ensure South African Health Products Regulatory Authority (SAHPRA) Compliance
• Assist in closing of GMP Audit and compliance findings and following up with relevant production personnel to action.
• Ensure that departmental plant maintenance requests are processed and completed on time.
• Generate periodic reports to establish the status of departmental PM requests.Reports any identified risks, hazards and incidents

Management of batch product labels

• Ensure expiry labels are requested in a timeous manner
• Ensure that Goods Issue labels and GI Slips are signed by the pharmacist and attached to the correct batch documents
• Ensure that Goods Receipt labels are signed by the pharmacist and available for attachment to the correct products with the correct information on the label
• Printing of all sample labels in a timeous manner
• Verification for correctness of labels and availability when required.
• Perform correct confirmations and goods receipt for the product yields manufactured to ensure that the correct labels are printed and that SAP reflects the correct quantities for product formulations

Employee time and attendance

• Daily monitoring of time keeping of all employees in the department.
• Maintenance of the Employee Overtime Template to track number of hours.
• Submit monthly report of Employee Overtime to the department Manager
• Printing of leave forms for the employees
• Collection and distribution of employee payslips and related personal documents

General administration

• Responsible for the general administration system within the department to ensure continual compliance with documented processes, procedures and cGMP.
• Coordination of documents sent to Document Warehouse for archiving and ensure that records are kept for traceability and easily retrievable for audits.
• Takes minutes of department meetings and distribute them timeously.
• Support in organising training, training rooms and training materials as required by the department.
• Assist with departments participation in company events to uphold the reputation of the department
• Participate in the continuous improvement and development in the department.
• Liaison with other departments
• Perform ad-hoc secretarial duties for department section heads and manager