QA Product Release Pharmacist

Johannesburg, Gauteng
Permanent
Full-time

23 days ago

Main Purpose Of Job Ensure all pharmaceutical and related activities, QA Product Release Pharmacist, are undertaken as per acceptable national and cGMP principles and legislation as well as GMP guidelines. Release of TPN, ensure product safety, quality and efficacy. Maintenance of all records related to release in an easily retrievable manner. Ensuring the in-process quality control is effective. Key Performance Areas (KPAS) Release of TPN Review of TPN documentation to ensure product has been compounded in accordance with company SOPs, GMP and regulatory standards Ensure patients safety regarding TPN administration by review of documentation and ensuring all investigations and deviations are documented, approved and are of a nature that will not affect product safety Resolution of all queries resulting from TPN compounding thereby ensuring product safety Release of product in accordance with marketing/dispensary requirements The Implementation of Quality Control Ensure that QA-IPC performs statutory required quality control verification checks in the compounding centre and record on the documents in accordance with all company SOPs , and GMP requirements . Manage quality checks that are routinely performed within the compounding centre Initiate quality risk assessments as and when required with regards to TPN production. Documentation/Systems Review of applicable SOPs ensuring that the new requirements are incorporated and taking global requirements into consideration Investigation, closure and follow up on applicable CAPAs, change controls and deviations to ensure timely closure and effectiveness of corrective action. Review and approval of all compounding GMP related documentation SAP Management of Stock Handling of all products and materials released and placed in quarantine within the SAP system to ensure there is no dispatch of stock that has not been released Ensure that discard of stock takes place within specified timeframe after approval of discard has been obtained Product Release Authorization to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labelling and drug products. Ensure release cover is managed for effective and efficient releases as required. As part of the QA release team and as required: Ensure imported product is released in accordance with logistics and marketing demand Review of data related to import product thus ensuring safety, quality and efficacy thereby ensuring that regulatory requirements are met, the review includes but is not necessarily limited to: Temperature loggers Original CoA from manufacturer Post importation CoA Sending and tracking of samples to laboratory to ensure there are not unnecessary product release delays
Required Level of Education: B. Pharm Degree At least three years experience within the pharmaceutical industry Sound knowledge of GMP Knowledge of aseptic production would be advantageous Skills & Experience: Ability to multitask and problem solving Attention to detail Decisive Experience with MS Word, Excel, PowerPoint, Outlook, SAP Operating in a high pressurized environment Operating with minimal degree of supervision

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