QA Pharmacist (Steriles)

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 implemented

Minimum 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