QMS Pharmacist

• 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 processes
• Review investigations arising from customer complaints, ensuring that complaints are thoroughly investigated, and effective corrective and preventative actions (CAPA’s) have been identified and implemented
• Perform and track internal audits / self-inspections of departments as per schedule; compile reports and follow-up on CAPA
• 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 APQR reports and initiate CAPA’s from the recommendation of these reviews
• Assist 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 Pharmacists
• 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, CAPA, risk assessments, and reprocesses.

Qualifications and Experience:

• B. Pharm
• cGMP skills
• Registration with South African Pharmacy Council
• 1 years’ experience in Quality Assurance
• 2 years’ experience in a pharmaceutical manufacturing environment would be preferable
• 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
  • Presenting and communicating information
  • Applying expertise and technology
  • Learning and researching
  • Planning and organising
  • Following instructions and procedures
  • Adapting and responding to change
  • Deciding and initiating action
  • Leading and supervising
  • Working with people
  • Adhering to principles and values
  • Coping with pressure and setbacks