Quality Assurance Specialist

6 days ago

Cape Town, Western Cape, South Africa iStaff Recruitment Full time
About the Role

We are seeking a highly skilled QA Pharmacist to join our team at iStaff Recruitment.

The successful candidate will be responsible for maintaining quality / service level agreements for all GXP Suppliers, performing 3 yearly reviews of all SLAs, and maintaining the status on the Approved Supplier list.

This role requires strong leadership skills, excellent communication abilities, and a keen eye for detail.


Responsibilities
  1. Initiate and maintain Quality / Service Level Agreements for all GXP Suppliers for all branches
  2. Perform 3 yearly review of all SLAs
  3. Maintain the status on the Approved Supplier list
  4. Initiate annual audit plan for both internal and external audits, plan, execute, report on and follow up on all observations noted, to ensure timely close out.
  5. Monthly update to internal and external audit plan with valid reasons provided if audits are postponed, also indicating audits that were conducted.
  6. Conduct as needed audits of processes/ departments or suppliers as may be necessary, resulting from problems that arise from time to time during the supplier management process
  7. Key involvement in all Corporate audits to ensure support is provided where required
  8. Key involvement in all regulatory audits to ensure support is provided where required
  9. Supply of required inputs to KPI reporting for local, region and global on aspects related to Quality Assurance function
  10. Prepare slides for Annual Quality Management Review Meeting
  11. Maintain a system for supplier evaluation and approval prior to purchase i.e Supplier Qualification.
  12. Co-ordinate corrective actions stemming from supplier performance reports
  13. Perform for cause audit of non-compliant suppliers that may be outside of annual audit plan.
  14. Maintain the Approved Supplier List with current information as and when required
  15. Maintain the supplier quality requirements on SAP.
  16. Ensure all SOPs required within the department are initiated, updated, trained and current.
  17. Review of applicable SOPs ensuring that new requirements are incorporated and taking Global requirements into consideration

Requirements
  • BPharm degree
  • At least 6 years of experience in QC
  • Manufacturing experience
  • Knowledge of cGMP principles
  • Medical Devices experience preferred
  • Knowledge of ISO 9000
  • Knowledge of quality auditing
  • Understanding of legislation for Manufacturing Pharmacy and regulatory processes

Benefits

A competitive salary of $120,000 - $180,000 per annum, plus benefits package including health insurance, retirement savings plan, and paid time off.

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