Jobs in Go!

To implement, maintain and improve the Quality Management System in order to ensure continuous compliance with SAHPRA and other international cGMP and Regulatory requirements. Key Responsibilities: Review, track and follow through on change controls, deviations and assess the impact of the change and deviation on quality systems and processesReview investigations arising from customer complaints, ensuring that complaints are thoroughly investigated, and effective corrective and preventative actions (CAPA’s) have been identified and implementedPerform and track internal audits / self-inspections of departments as per schedule; compile reports and follow-up on CAPAAssist with external audits were necessary; compile reports and follow-up on CAPAParticipate in risk assessments on QMS and departmental processes to assess risk and identify mitigating actions and controlsConduct root cause investigations into incidents and deviations identifying root cause and CAPAParticipate in Quality Management Reviews to identify trends in QMS processes and implement CAPAs to address any deficienciesReview and approve Master Batch Documents for compliance in line with the dossierReview APQR reports and initiate CAPA’s from the recommendation of these reviewsAssist with review of completed batch records (manufacturing and packaging) to ensure compliance with processes and identifies any queries to be addressed to enable release of finished products by the Release PharmacistsControlling and assigning expiry dates for finished products on the ERP systemReview Packaging Material test reportsPrepare monthly reports on the status of deviations, change controls, CAPA, risk assessments, and reprocesses. Qualifications and Experience: B. PharmcGMP skillsRegistration with South African Pharmacy Council1 years’ experience in Quality Assurance2 years’ experience in a pharmaceutical manufacturing environment would be preferableComputer Literacy – MS Office (proficient in Excel, Word, and Power Point)QMS and pharmaceutical knowledgeUnderstand the requirements of the relevant Acts and regulations governing the pharmaceutical industryCompetencies Presenting and communicating informationApplying expertise and technologyLearning and researchingPlanning and organisingFollowing instructions and proceduresAdapting and responding to changeDeciding and initiating actionLeading and supervisingWorking with peopleAdhering to principles and valuesCoping with pressure and setbacks https://protool.gumtree.co.za/external-link-browser.html?urlaHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8zNjc2OTgxMzUzP3NvdXJjZT1ndW10cmVl&jid1316454&xid3676981353 Apply Now

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