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Production Administrator

3 weeks ago

Pinetown, South Africa NBISA Recruitment Full time

**Job Advert Summary**:

- 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

**Minimum Requirements**:

- Relevant Tertiary qualification
- 1-year experience in an administrative role. Experience within the pharmaceutical environment, with an understanding of cGMP and GDP will be an added advantage
- Exposure to SAP or other Electronic control systems
- Proficiency in Microsoft Word, Excel and PowerPoint

**Duties and 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
- Goods Receipt of product yields on SAP after Pharmacist verification, reconciliation and SAP confirmation.
- 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 after the completion of the 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.
- Attend to MCD queries where possible.
- Maintain document release target of two weeks from production to ORP.

**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

**Control of departmental log books**
- 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**
- 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
- Assisting with updating the skills matrix template

**Inventory management and procurement services**
- Monitor the assigned departmental stock requirements and levels.
- 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

**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 available for attachment to the correct products with the correct information on the label
- Verification for correctness of labels and availability when required.
- Perform correct goods receipt of product quantities manuf