Quality Assurance Pharmacist

6 months ago

Johannesburg, South Africa Unique Personnel Full time

**Job Number**
- 72382

**Job Type**
- Permanent

**Job Title**
- Quality Assurance Pharmacist

**Computer Skills**
- ISO 9000,MS Office,SAP

**Industry**
- Medical

**City**
- Johannesburg

**Province**
- Gauteng
- Reporting to the Senior Quality Systems Manager- Purpose of position:
- Implement and maintain all elements needed to ensure compliance with Quality Assurance principles and systems as per regulatory, cGMP, Pharmaceutical Industry Guidelines, ISO 9000, FKSA and Global requirements, as applicable.- Key Responsibilities:
- 1. Quality Agreements:
- 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- 2. Audits:
- 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- 3. KPI reporting & Annual Quality Management Review:
- 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- 4. Supplier Management:
- 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.- 5. Standard Operating Procedures:
- 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- Ensure relevant global SOP’s are adopted locally as required timeously.- 6. Quality Systems:
- Investigation, closure and follow up on applicable Risk Assessments, CAPA, Change Controls and Events to ensure timely closure and effectiveness of corrective action- 7. Product Release:
- Review and evaluate BMRs and BRLs prior to final product release.- Evaluation of documentation to release products.- Processing of product release transactions- 8. General:
- Provide and support the Senior Quality Systems Manager/Head of Quality with related quality projects as and when required- Assist the QA Document Controller with issuing Production Documents.- Effective provision of QA support to the branches, assist in and conduct QA related investigations as needed- Establish and maintain positive working relationships with others, both internally and externally, to achieve the goals of the company- Ensure all training planned is completed within timeframe.-
**Inherent Requirements**
- Qualification:
- Minimum BPharm degree- Skills & Experience:
- 2-3 years’ experience in a Manufacturing Pharmacy- Work experience in a sterile environment preferred.- Thorough knowledge of cGMP principles- Knowledge of ISO 9000- Knowledge of quality auditing- Knowledge of supplier management- Understanding of legislation for Manufacturing Pharmacy and regulatory processes- General Management**What Qualification**
- BPharm degree

**Minimum Qualification**
- Bachelors

**Status**
- Available

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