Description:
Key Outputs:
Assist with external audits were necessary; compile reports and follow-up on CAPA Participate in risk assessments on QMS and departmental processes to assess risk and identify mitigating actions and controls Conduct root cause investigations into incidents and deviations identifying root cause and CAPA Participate in Quality Management Reviews to identify trends in QMS processes and implement CAPAs to address any deficiencies Review and approve Master Batch Documents for compliance in line with the dossier Review Annual Product Quality Review reports and initiate CAPA’s from the recommendation of these reviews Compile, review and approve QMS SOP’s ensuring compliance to the SAHPRA cGMP Guidelines Train and implement the QMS SOP’s ensuring understanding by the relevant staff Review, track and follow through on change controls, deviations and assess the impact of the change and deviation on quality systems and processes Perform and track internal audits / self-inspections of departments as per schedule, compile reports and follow-up on corrective and preventive action Controlling and assigning expiry dates for finished products on the ERP system Review Packaging Material test reports Prepare monthly reports on the status of deviations, change controls, corrective and preventive action, risk assessments, and reprocesses Monitor compliance with cGMP requirements in the sterile plant Audit all sterile plant batch records for compliance and release Participate in validation programs, including media fill Review investigations arising from customer complaints, ensuring that complaints are thoroughly investigated, and effective corrective and preventative actions have been identified and implementedMinimum Requirements:
Bachelor Pharmacy Degree Registration with South African Pharmacy Council 1 years’ Sterile experience in aseptic manufacturing 2 years’ QA experience within a pharmaceutical manufacturing environment cGMP skills Computer Literacy: MS Office (proficient in Excel, Word, and Power Point) QMS and pharmaceutical knowledge Understand the requirements of the relevant Acts and regulations governing the pharmaceutical industry.Competencies:
Deciding and initiating action Leading and supervising Working with people Adhering to principles and values Presenting and communicating information Applying expertise and technology Learning and researching Planning and organizing Following instructions and procedures Adapting and responding to change Coping with pressure and setbacks
26 Aug 2022;
from:
gumtree.co.za