Orp Administrative Assistant

2 weeks ago

Pinetown, KwaZulu-Natal, South Africa NBISA Recruitment Full time

Job Advert Summary:

To assist in ensuring that the ORP systems operate in compliance with set procedures and cGMP.


To ensure efficient administrative procedures are executed within the Product Release Authorisation, Clinical Affairs and Regulatory Affairs departments of ORP, including filing of all applicable records and retention samples.

To provide administrative support to ORP Managers and staff

To collate and provide PCR reports and BMR audit statistics to all relevant stakeholders

Specific Operational Requirements

  • May be required to work overtime/travel to meet the business needs.
  • Must be prepared to work shifts/weekends/public holidays when needed.

Minimum Requirements:

  • Post Basic Pharmacist Assistant
  • Relevant Tertiary Qualifications
  • Exposure to SAP or other Enterprise Resource Management software
  • Proficiency in Excel
  • Experience in GMP environment
  • Computer literacy (MS Office, SAP, Internet)
  • Previous experience in administrative support duties, e.g. documentation control, recordkeeping, filing, data capture, etc. as well as knowledge of pharmaceutical systems

Duties and Responsibilities:

Administrative Support:

  • Maintenance of the implemented Administration System within ORP to ensure continual compliance with documented processes.
  • Ensure that the department functions efficiently with the constant supply of the required service to all stakeholders.
  • Control of PRA and NBIgenerated information. These records include, but are not limited to environmental monitoring documents, batch manufacturing records, packaging documents and related records to ensure preservation and easy retrieval.
  • Ensure the appropriate filing of documentation for Regulatory Affairs, Clinical Affairs and the PRA department.
  • Ensure effective communication with all stakeholders.
  • Ensure timeous creation, processing and follow up of all ORP department requisitions created on SAP.
  • Process plant maintenance notifications on SAP and liaise with Engineering Services.
  • Track of all departmental nonstock items through procurement to ensure timeous receipt.
  • Create prepayment memos, when required and liaise with Finance to this effect.
  • Maintain and update online departmental SHE file to ensure compliance.
  • Daily Rapid Action Meeting Update reporting to the Product Release Authorisation Manager.

Filing of documentation

  • Ensure that all documents are filed immediately and appropriately for easy retrieval and use.
  • Maintain an appropriate filing system for use by staff within ORP.
  • Preaudit of pharmaceutical MCD as per checklist for document control purposes.
  • Ensure that batch documentation for intermediates is appropriately stored for later use in final product batch document audits.
  • Ensure no unauthorised access to the document room.

Batch Release Scheduling Activities:

  • Ensure that all required batch documentation is ready and available for review by the Product Release Assistants in accordance with the Projected Release Plan, and any urgent priorities.
  • Use appropriate SAP transactions to establish which intermediate batch documentation is required for ampoule products.
  • Ensure that all intermediate and/or final product batch documentation are timeously received, in accordance with the Projected Release Plan.
  • Ensure related Albusol and Polygam batch documents are released prior to submitting the AVS and GGT intermediate documents to QA.
  • Ensure noncompliant batch documents are correctly collated, compiled and attended in a timely and appropriate manner.
  • Ensure that the internal monitoring mechanism (Throughput Monitor) for the Projected Release Plan is maintained and updated continuously.

Maintenance of Registers

  • Ensure that all documentation received into PRA is recorded on both the Throughput Monitor and the PRA Batch Document Receipt logbook.
  • Continuously update and maintain all online registers to ensure compliance
  • Ensure that the PRA Batch Document Receipt logbooks are cGMP compliant and does not have conflicting information recorded.
  • Ensure that all stakeholders sign the appropriate logbook when delivering documentation to PRA.
  • Audit completed logbooks and submit to QA for archiving.
  • Request new logbooks in a timeous manner and ensure logbooks are available for use on time

Generate statistics

  • Generate audit statistics using information supplied by all stakeholders and report on these monthly.
  • Compile Product Release Pharmacist Assistant's Productivity Reports for review by DRP
  • Compilation and submission of the Monthly Process Control Review report for review by DRP.
  • Highlighting and escalating discrepancies and emerging trends observed, with respect to batch document audit queries, to the DRP
  • Ensure timely circulation of reports and secure storage on NBI network.

Ad-hoc activities

  • Support in organising meetings, training, training venues, materials and any other requirements, as requested by ORP Manage

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