Qualified Person (QP)
- Experience Level
- Experienced (non-manager)
- To ensure that all processes/stages in the manufacture, testing and packaging of products has been adhered to, according to the cGMP/cGLP/Regulatory requirements.
- Develop and improve quality systems by identifying areas for improvement and take corrective action as required to ensure continuous improvement in accordance with Company Continuous Improvement Process.
- Review change proposals and related documentation for compliance with Regulatory approvals and GMP requirements.
- Ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLPs, SOPs, regulatory regulations and guidelines, H & S and Environmental guidelines.
- To review and approve batch documentation, investigation reports, change controls, QRMs, SOP’s and qualification reports, ensuring they are completed right first time and in full in accordance with Good Manufacturing Practice requirements.
- To review and release batches according to shipment schedule ensuring all batches are in compliance with regulatory requirements.
- Qualified Pharmacist or Graduate of Diploma in Pharmaceutical Manufacturing Technology or equivalent “Qualified Person” status
- Proven experience within the Pharmaceutical industry in a leading QA/QC/Compliance role.
- Broad Knowledge of Analytical Techniques and Experience in HPLC
- Excellent knowledge of regulations and sources of regulatory information.
- Understanding of Production and Laboratory systems to effect judgement decisions consistent with business needs.
- An understanding of internal/external customer requirements and an ability to respond promptly to needs.
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