Job Description

Key responsibilities:

• Ensure compliance with ISO standards including ISO 9001, 14001, 45001, and 13485.
• Prepare, review, and implement Standard Operating Procedures (SOPs), guidelines, and policies in alignment with AKI QA standards and international best practices such as ISO/GDP/HACCP.
• Regularly update and improve existing SOPs to enhance quality and compliance.
• Ensure the facility remains compliant with federal, state, and local regulations, including MOHAP/DM requirements.
• Monitor regulatory updates and disseminate relevant changes to the team.
• Implement necessary actions to maintain compliance and quality assurance.
• Conduct internal audits to assess adherence to regulatory requirements.
• Develop and deliver training programs on QA guidelines, SOPs, and best practices.
• Ensure continuous professional development of staff to maintain high-quality operational standards.
• Conduct regular quality training sessions and workshops.
• Monitor staff adherence to SOPs and provide corrective actions when necessary.
• Actively participate in risk assessment processes to identify potential risks in operations.
• Develop and implement mitigation plans to minimize risks and ensure compliance with risk management protocols.
• Ensure staff awareness of risk factors and mitigation strategies.
• Conduct regular reviews to evaluate the effectiveness of implemented risk control measures. |
• Conduct internal and external audits to ensure compliance with QA standards.
• Collaborate with other departments to improve quality processes and efficiency.
• Prepare reports and documentation related to QA activities.
• Support incident investigations and implement corrective actions to prevent recurrence.

Experience Qualifications & Skills:

• Bachelor’s/Master’s degree in Pharmacy, Quality Assurance, or a related field.
• Strong knowledge of quality management systems, regulatory requirements, and industry standards.
• Experience in handling audits, regulatory compliance, and risk management.
• Excellent communication, leadership, and training skills.
• Ability to analyze data and generate actionable insights for continuous improvement.