QA Pharmacist

7 days ago

Midrand, South Africa Dalitso Holdings Full time

**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
- Learning and researching
- Planning and organizing
- Following instructions and procedures
- Adapting and responding to change
- Coping with pressure and setbacks

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