Key Responsibilities:

Quality Management System (QMS):

• Develop, implement, and maintain QMS in compliance with local and international regulations (e.g., ISO 13485, GDP).
• Regularly review and update Standard Operating Procedures (SOPs).
• Ensure documentation control and record-keeping for all quality-related activities.
• Monitor compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).

Product Compliance and Release:

• Review and approve product batches for distribution, ensuring they meet regulatory and company standards.
• Conduct quality checks on incoming and outgoing products.
• Coordinate with suppliers and manufacturers for product quality issues.
• Ensure product labeling and packaging meet regulatory requirements.

Audits and Inspections:

• Conduct internal audits to ensure compliance with QMS, SOPs, and regulatory requirements.
• Prepare for external audits and regulatory inspections.
• Address audit findings with corrective and preventive actions (CAPA).
• Maintain audit records and ensure timely resolution of non-compliance issues.

Complaints and Non-Conformance Management:

• Handle product complaints, ensuring timely investigation, root cause analysis, and reporting.
• Manage non-conformance reports (NCR) and implement CAPA.
• Communicate with regulatory authorities for adverse events, if required.
• Ensure documentation and traceability of all reported issues.

Training and Development:

• Conduct quality training programs for staff on SOPs, QMS updates, and regulatory changes.
• Ensure personnel are aware of quality and safety standards.
• Develop training materials to enhance compliance awareness among employees.

Supplier and Vendor Management:

• Evaluate and qualify suppliers and vendors.
• Maintain an approved supplier list and conduct supplier audits as needed.
• Establish quality agreements with suppliers to ensure consistent compliance.

Regulatory Affairs Support:

• Assist the Regulatory Affairs team in product registration and renewal processes.
• Ensure labeling and promotional materials comply with regulations.
• Keep updated with changes in regulatory guidelines and implement necessary adjustments.

Continuous Improvement:

• Participate in quality improvement initiatives.
• Recommend changes to enhance product quality and operational efficiency.
• Analyze trends in quality data and suggest process enhancements.

Qualifications and Skills:

Education:

• Bachelor’s degree in Pharmacy, Biotechnology, Life Sciences, or a related field.

Experience:

• Minimum of 2 years in Quality Assurance within the medical devices or pharmaceutical industry.

Skills:

• Strong knowledge of GDP, ISO 13485, and local regulatory requirements.
• Excellent attention to detail and analytical skills.
• Strong communication and interpersonal skills.
• Proficiency in MS Office and quality management software.
• Ability to multitask and work under tight deadlines.
• Strong problem-solving and decision-making capabilities.

Key Performance Indicators (KPIs):

• Compliance rate with internal and external audits.
• Timely closure of CAPA and NCR.
• Product complaint resolution time.
• Training completion rates.
• Supplier compliance and audit performance.

Working Conditions:

• Office-based with occasional visits to warehouses and suppliers.
• May require travel for audits and inspections.
• Must be available for emergency quality-related issues.

Salary : 💵 5,000 QAR 💵
All Inclusive salary

To apply for this position, please submit your updated CV and cover letter.

Only shortlisted candidates will be contacted for further evaluation.

Please note that the specified requirements are mandatory for this role. Kindly ensure that you meet the qualifications before applying.