Quality Assistant
2 weeks ago
**Responsibilities**:
Assist with all QA Departmental functions as listed, but limited to:
- Internal and External Audit Administration Management
- SOPs and SOP Training Administration
- Product Quality Review
- Validations
- Change Controls
- Document Control (Specifications, Master Copies)
- Non-Conformances
- Out of Spec (OOS)
- Deviations
- Out of Trends (OOT)
- CAPAs
- Trend Management
- Pest Control
- Initiate and assist with Technical Quality Agreements
- Assist with approval process of suppliers/service providers
- QMR Meeting preparation
- BMR & BPR administration and review (QC & Micro)
- Sample Management
- Stability Program Liaison with IPS
- Compliance Checks as specified from QA
- Temperature monitoring
- Waste Destruction
- Risk Assessments
- Printed Packaging Control
- Rework of Rejects Goods
TRAINING
- Monitor that all employees in all the Departments are fully trained to implement GxP and on all the approved SOPs applicable to the different departments.
KNOWLEDGE REQUIRED
- Good computer literacy, especially Excel
- Knowledge of cGxP regulations.
- Qualified Pharmacist Assistant
EXPERIENCE REQUIRED
- Minimum of 2 Years QA and QC experience essential.
- Standard Operating Procedure (SOP) compilation.
SKILLS REQUIRED
- Effective communication and interpersonal skills
- Exceptional attention to detail
- Strong planning and organising skills
- Can work well under pressure
- Customer Focus
- Detail oriented
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