QA Pharmacist

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We also use your personal information to respond to your inquiries, to verify your information and to share information with you. Your personal information will be securely stored by the Human Capital Department and it will be retained for a period of up to 12 months as of the closure of the application procedure if your application is unsuccessful, and in case of a successful application and you are hired, your data will be transferred to your personal employee file. By applying for this position, you consent to us processing your personal information. We reserve the right to make an appointment. If you have not heard from us within 30 (thirty) days of the closing date, please accept that your application was unsuccessful. Correspondence will be entered into only with shortlisted candidates. Please note that this appointment will be made in line with company’s employment equity policy and divisional employment equity targets Job Pupose: The QA Process Pharmacist is responsible for ensuring compliance with SAHPRA, PIC/S, GMP, and internal quality system requirements through the effective management of deviations, CAPAs, investigations and Defect trend analysis. The role supports continuous improvement initiatives by ensuring that investigations and root cause analysis are performed in such a way that provides lasting solutions to the deviations experienced. Monitor the effectiveness of the corrective actions by tracking of recurrent deviations investigations and where necessary further investigate the root cause of recurrent deviations with the aim of identifying the true root cause of the recurrent deviations. MAIN TASKS / RESPONSIBILITIES: Deviation Management Performs an initial review of the deviation raised on Caliber to ensure that all the information required to approve the deviations has been recorded and conducts interviews with the initiator of the deviation to ensure that the correct description of the deviation has been captured. Changes the status of the batches placed on hold, under investigation and rejected on Oracle. Evaluate the impact of deviations on product quality, patient safety, regulatory compliance, and business operations. Review of deviations raised in AICC to ensure that the appropriate action has been taken to mitigate the non-conformance and that the investigation, root cause analysis have been performed satisfactorily and that the corrective action and preventative action taken is appropriate to ensure that the non -conformance does not recur. Follows up on open deviations and CAPAs to ensure timeous closure of the QMS documents pertaining to non – conformances. Escalate critical quality issues to management where required. Prepares a spreadsheet of recurring deviations every quarter, conducts meetings with the all the stakeholders of the recurring deviations to discuss alternative solutions to eliminate the non-conformance. Follow up on the implementation of the alternative solutions, monitor the effectiveness of the corrective action for a period of three months. Review of the Defect Trend Analysis Records Review of all the defect trend analysis records (P3s) to determine if there is a trend of defects developing in a class of products and evaluate if the trends that have been identified are such that additional tests must be performed on the batches before a batch is released. Review the types and number defects isolated on each batch and determine whether the defects experienced fall within the standard as determined by the IPQC department and if the defects are above the standard, decide on whether a batch can be released without additional testing. Reviews the causes and corrective action for each defect identified in a batch, to ensure that adequate corrective action has been taken to prevent an escalation to a non -conformance, where quality, patient safety and regulatory requirements are compromised Continuous Improvement Identify opportunities to improve quality system effectiveness. Analyze quality metrics and trends to drive process improvements. Participate in quality improvement projects and cross-functional initiatives. Promote quality culture and compliance awareness throughout the organization. Training and Support Provide guidance to staff on deviation management, CAPA processes, and quality system requirements. Support departmental compliance initiatives.