QA Pharmacist (Steriles) - Midrand
Key Outputs: Assist 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 Annual Product Quality Review reports and initiate CAPA’s from the recommendation of these reviewsCompile, review and approve QMS SOP’s ensuring compliance to the SAHPRA cGMP GuidelinesTrain and implement the QMS SOP’s ensuring understanding by the relevant staffReview, track and follow through on change controls, deviations and assess the impact of the change and deviation on quality systems and processesPerform and track internal audits / self-inspections of departments as per schedule, compile reports and follow-up on corrective and preventive actionControlling and assigning expiry dates for finished products on the ERP systemReview Packaging Material test reportsPrepare monthly reports on the status of deviations, change controls, corrective and preventive action, risk assessments, and reprocessesMonitor compliance with cGMP requirements in the sterile plantAudit all sterile plant batch records for compliance and releaseParticipate in validation programs, including media fillReview investigations arising from customer complaints, ensuring that complaints are thoroughly investigated, and effective corrective and preventative actions have been identified and implemented Minimum Requirements: Bachelor Pharmacy DegreeRegistration with South African Pharmacy Council1 years’ Sterile experience in aseptic manufacturing2 years’ QA experience within a pharmaceutical manufacturing environmentcGMP skillsComputer 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 industry. Competencies: Deciding and initiating actionLeading and supervisingWorking with peopleAdhering to principles and valuesPresenting and communicating informationApplying expertise and technologyLearning and researchingPlanning and organizingFollowing instructions and proceduresAdapting and responding to changeCoping with pressure and setbacks https://protool.gumtree.co.za/external-link-browser.html?urlaHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS80MDgxMTIzMDM5P3NvdXJjZT1ndW10cmVl&jid1311351&xid4081123039
Apply Now
Facebook
WhatsappRelated Jobs
Qa Pharmacist Midrand - South Africa
Specialist Search Recruitment
...
QA Pharmacist with Production background (to oversee QA of 3rd party manufacturers). Midrand. R70k R60k to R70k guaranteed 13th cheque, neg. - South Africa
Specialist Search Recruitment
...