Quality Assurance Specialist
4 weeks ago
We are seeking a highly skilled QA Pharmacist to join our team at iStaff Recruitment. As a QA Pharmacist, you will be responsible for ensuring the quality of our pharmaceutical products and services.
Key Responsibilities:- Initiate and maintain Quality/Service Level Agreements for all GXP Suppliers for all branches
- Perform 3-yearly review of all SLAs
- Maintain the status on the Approved Supplier list
- 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
- Monthly update to internal and external audit plan with valid reasons provided if audits are postponed, also indicating audits that were conducted
- 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
- Key involvement in all Corporate audits to ensure support is provided where required
- Key involvement in all regulatory audits to ensure support is provided where required
- Supply of required inputs to KPI reporting for local, region, and global on aspects related to Quality Assurance function
- Prepare slides for Annual Quality Management Review Meeting
- Maintain a system for supplier evaluation and approval prior to purchase i.e. Supplier Qualification
- Co-ordinate corrective actions stemming from supplier performance reports
- Perform for cause audit of non-compliant suppliers that may be outside of annual audit plan
- Maintain the Approved Supplier List with current information as and when required
- Maintain the supplier quality requirements on SAP
- Ensure all SOPs required within the department are initiated, updated, trained, and current
- Review of applicable SOPs ensuring that new requirements are incorporated and taking Global requirements into consideration
- Grade 12
- BPharm degree
- At least 6 years of experience in QC
- Manufacturing experience
- Knowledge of cGMP principles
- Knowledge of ISO 9000
- Knowledge of quality auditing
- Understanding of legislation for Manufacturing Pharmacy and regulatory processes
Please ensure your CV is in WORD or PDF format, and not scanned. Our software will not be able to match you to positions if it is scanned, therefore you might never get feedback from us. Scanned CVs will not be considered.
Please accept your application as unsuccessful if you had no feedback within 7 days of applying. We regret that due to the high volume of applications received, we are unable to acknowledge every application. We will keep your CV on our database and match to other suitable positions, but this won't be possible if your CV was scanned. We will contact you in future should you match a different position.
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