Quality Assurance Pharmacist
5 months ago
Our client, Pharmaceutical Manufacturing concern, has a role for a QA Pharmacist to join their team.
**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.
**Desired Experience & Qualification**
**Qualification**:
- Minimum BPharm degree
**Skills & Experience**:
- 6 years’ or more experience in Manufacturing and with QC (essential)
- Work experience in a sterile environment preferred.
- Experience with medical devices (essential)
- 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
**Salary**: R50 000,00 - R65 000,00 per month
**Education**:
- Bachelors (required)
**Experience**:
- Quality Assurance: 6 years (required)
Ability to Commute:
- Midrand, Gauteng (required)
Ability to Relocate:
- Midrand, Gauteng: Relocate before starting work (required)
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