Junior Quality Assurance Pharmacist

SUMMARY:
-

POSITION INFO:

Main Purpose of Job

• Maintaining the highest standards of product quality and compliance within the company.
• Assisting with overseeing compliance with relevant legislation GMP, GWP, GDP, and ISO 13485 requirements for medical devices.
• Assisting with managing overall product quality control, implementing quality systems effectively, and assisting with managing stock to ensure product integrity and safety.

Key Performance Areas:

Ensuring Compliance with Legislation, including:

• GMP/GWP/GDP adherence
• Accurate record maintenance
• Conducting self-inspections
• Ensuring compliance with Standard Operating Procedures (SOPs), ISO13485 requirements and conducting regular reviews
• Conducting audits of manufacturers, packers, and laboratories
• Monitoring temperature controls
• Managing contracts with third parties and distribution agreements
• Investigating technical complaints and conducting trend analysis
• Conducting annual product reviews
• Vendor Qualification
• Overseeing disposal of rejected stock and retaining stock destruction certificate.

Managing Quality Standards, including:

• Sampling products for re-testing
• Facilitating post-importation testing
• Monitoring standard levels in the laboratory
• Auditing and controlling batch documentation
• Releasing of finished products
• Ensuring product quality in the market
• Managing storage and controlling retention samples
• Submitting status reports
• Approving artwork/packaging
• Reviewing and approving validation reports
• Controlling development and approval of new product barcodes
• Reviewing and approving master documentation
• Requesting and approving stability test results
• Conducting product quality reviews
• Conducting recalls and mock recalls
• Analyzing deviations and trends.

Responsible for System Implementation, including:

• Monitoring temperature of incoming shipments
• Managing documentation and control
• Validating stock control system for authorized product release and automatic quarantine/release of stock
• Conducting mock recalls
• Maintaining the Quality Manual
• Implementing Risk Management procedures as per ISO13485 requirements
• Reviewing and updating SOPs
• Keeping informed of regulatory changes impacting Austell’s quality systems
• Ensuring continuous update and implementation of quality systems to reflect current practices.
• Ensuring availability of information for audit purposes and maintain backups

EDUCATION:

• Bachelor of Pharmacy Degree
• Minimum completion of Internship and Community Services

SKILL REQUIREMENT:

• Intermediate proficiency in Microsoft Office
• Excel
• Word
• PowerPoint
• Outlook
• BI
• Pastel
• Smartsheet
• MEDIQ