Quality Assurance Pharmacist

**Job Number**
66977
**Job Type**
Permanent
**Job Title**
Quality Assurance Pharmacist
**Computer Skills**
ISO 9000,Ms office Suite
**Industry**
Medical
**City**
Johannesburg
**Province**
Gauteng
Reporting to Senior Quality Systems Manager
MAIN PURPOSE OF JOB:
Implement and maintain all elements needed to ensure compliance with Quality Assurance principles and systems
KEY RESPONSIBILITIES:
1. Quality Agreements:
Initiate and maintain Quality / Service Level Agreements for all Suppliers for all branches
Updated list of quality agreements initiated and signed off. Quality agreements filed in a central database.
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
3. KPI reporting:
Supply of required inputs to KPI reporting for local, region and global on aspects related to Quality Assurance function
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 audit of non-compliant suppliers that may be outside of annual audit plan.
Maintaining the approved supplier list
5. Customer Complaints:
Management of Customer complaints
Monitor the complaints system - ensure effective complaint management
6. 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.
7. 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
8. TPN Product Releases:
Assist the Quality Control Manager with TPN releases over weekends on a roster basis or as and when necessary.
9. Staff Management:
Manage customer complaint officer - maintain job profile, draft performance contract, set clear KPA’s, training, staff management.
10. 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
**Inherent Requirements**
Minimum education:
B. Pharm
Skills &
Experience:
2-3 years’ experience in a Manufacturing Pharmacy
Quality Auditing Experience essential
Work experience in a sterile environment an advantage
Knowledge and experience in Supplier Management
Thorough knowledge of cGMP principles
Knowledge of ISO 9000
Understanding of legislation for Manufacturing Pharmacy and regulatory processes
General Management
Competencies:
- Self-starter
- Solution oriented
- Multitasking
- Problem solving Leadership/influencing
- Quality orientation
- Strategic and conceptual thinking
- Excellent planning and organizational skills with demonstrated ability to execute projects on time and to budget
- Deadline driven
- Decision making
- Team player / excellent interpersonal abilities / positive working relationships
- Enquiring mind with attention to detail
- Ethical behavior
- Effective communication
- Able to function effectively under pressure with limited supervision
- Enthusiastic team player
**What Qualification**
B. Pharm
**Minimum Qualification**
Bachelors
**Status**
Available