QMS Officer

Job Purpose 

To review non-conformance/ Out of spec reports, deviation requests and subsequent correspondence thereof, and drive these to timeous closure.
• To Meet regulatory expectations of science‐ and risk‐based product knowledge management by assessing risk in the QMS scope.
• Provide Quality Intelligence by compiling, reviewing and analyzing Product Quality Reviews (PQR) on behalf of the Applicant.
• To manage the budget and purchase order traffic for Stability and PQR activities.
• To evaluate suitability of product for the South African market and recommend process/product improvements based on the reviews conducted.
• To review Promotional Material relevant to scope.
• To perform Quality Due Diligence on new deals to ensure that quality, technical and business risk are assessed from a QMS perspective and provide the business with final outcome.

Key Accountabilities

• QA Process Optimisation and Efficiency
• Simplification and automation of QMS processes through implementation of software solutions.
  Captures continual improvement suggestions on the Continual Improvement Tracker according to the relevant SOP.
  Maintenance and improvement of Track Wise.
  Facilitation of training / conduct training of processes and systems to end user.
  To identify and drive process simplification and cross functional integration through the liaison with key stakeholders.
• QA Reporting
• Simplification and automation of QA reports (as required by SOPs / Policies) by leveraging data from available databases, example Track Wise, SAP.
  Facilitation and implementation of real-time reporting by implementation of QlikView format or similar/alternate platform.
  Where automated reporting is not possible, assessment of data and manual compilation of reports.
  Present data to QA leadership to enable informed decision making based on data.
  Completion of reports and files as per timelines applicable SOPs/Policies.
  Scheduling of Quality Management Review meetings.
  Draft and finalise Quality Management Review meeting minutes and ensures that the report is approved and filed
• Review approval of Non-conformances (NC), Deviations and Out of Specification
• Reviews and evaluates NC/deviation/ OOS/OOT notification upon receipt.
  Discusses the impact of the notification with the relevant second reviewer.
  Responds to the initiator of the NC/deviation/OOS/OOT within the specified timeline.
  Requests further documentation in support of final decision on NC/deviation/OOS/OOT.
  Escalates concerns to the Director - QA Operations (SA) timeously.
  Actively drives all open NC/deviations/OOS/OOT to closure.
  Maintains NC/deviations/OOS/OOT logs, ensuring NC/deviations/OOS/OOTs are logged correctly, and all supporting information is uploaded correctly.
• Supports the Effective Implementation and Management of the Quality Management System (QMS)
• Assist with or Performs Quality Risk Management reviews as part of the FMECA team, in accordance with the relevant SOP.
  Creation and maintenance of Governance / audit presentations and update of QA Organograms.
• Evaluating the suitability of products for South African market, by interpreting data and capturing quality and regulatory aspects in the PQR Report and PQR Summary Report:
• Requesting and evaluating PQR data/reports provided by each manufacturing unit, for each product, according to the PQR schedule.
  Reviews PQR reports compiled from manufacturing units for accuracy and completeness as well as for lifecycle management commitments, and compile product quality reports.
  Evaluate manufacturer data and performance, and interpret analytical, manufacturing, compliance and regulatory data.
  Draw conclusions from data and statistical reports and identify any trends in the process.
  Interpret analytical, manufacturing, compliance and regulatory data and draw conclusions from data and statistical reports.
  Verify the consistency of existing processes and highlight any trends.
  Establish review and verification of process with key subject matter experts for the evaluation of trends and determination of corrective/preventive actions (CAPAs) for inclusion within the PQR report.
  Trending of final product (FP) and post importation testing (PIT) assay results for data generation for possible PIT exemption.
  Capture Regulatory Affairs Variations and post marketing stability commitments and identify deficiencies.
• Stability Review and Temperature Excursion
• Maintain stability schedule on SharePoint including:
  Annual stability
  Data generated for regulatory variation filing identified via Change Requests.
  Data required to be generated as a result of CAPA or deviations.
  Requests outstanding reports from local and international manufacturing units.
  Reviews reports received against dossier specifications and limits.
  Uploads reports to the relevant folder on SharePoint.
  Escalates any non-conformances to management.
  Request for disposition of product exposed to temperature outside of the approved storage conditions received from pharmacies, wholesalers, government facilities or distributors.
• Reworks, Batch Inspections and Reprocessing
• Receives the request for the rework / inspection to be performed from the Marketing Manager / Demand Planners / Batch Release team.
  Performs a risk assessment or investigation (if required) and compiles a report as needed.
  Identify third party packing contractors for reworks or inspections.
  Liase with third party packing contractors and requests a quotation for the rework.
  Request approval for the quotation for the rework.
  Reviews and approves the rework protocol supplied by the third party packing contractor.
  Provides Master Documents for filing to the
  Change Control / Request team.
  Liaises with CDG for delivery of stock to the third party packing contractor for rework / inspection.
  Logs and tracks reworks / inspections on the Reworks Log.
• Review and approval of promotional material and communication letters
• Reviews promotional material and launch letters against relevant legislation (Medicines Act, Marketing Code etc.)
  Checks for compliance to the relevant legislation, as well as spelling and grammar for SEP products.
  Approves the material as part of the signature panel.
  Uploads all approved versions to the relevant Promotional Material folder on SharePoint.
  Escalates areas of risk identified within promotional material item text/imagery
• Projects, General Administration and Support
• Assists with any reasonable duties as requested by QA management to ensure that the department is functioning optimally and meeting its set objectives and goals
• Financials, Cost and Budget
• Review and approve PQR/Stability quotations.
  Perform GRN on SAP for stability and PQR purchase orders created.
  Compile/Review stability budget annually.
• Pharmacovigilance
  Awareness of the Cipla Pharmacovigilance process and provide internal support during Pharmacovigilance audits.