QA Pharmacist

SUMMARY:
We require a QA Pharmacist with pharma manufacturing experience in Midrand area.

POSITION INFO:
Minimum Requirements

• Grade 12
• 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

• Initiate and maintain Quality / Service Level Agreements for all GXP Suppliers for all branches 
• Perform 3 yearly review of all SLA’s
• 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 SOP’s required within the department are initiated, updated, trained and current. 
• Review of applicable SOP’s ensuring that new requirements are incorporated and taking Global requirements into consideration