Quality Assurance Pharmacist

7 months ago

Goodwood, South Africa RNB Placements Full time

**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**: R55 000,00 - R65 000,00 per month

**Education**:

- Bachelors (required)

**Experience**:

- QA: 6 years (required)

Ability to Commute:

- Goodwood, Western Cape (required)

Ability to Relocate:

- Goodwood, Western Cape: Relocate before starting work (required)

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