Regulatory Compliance Officer

4 days ago

Ras alKhaimah, Ra’s al Khaymah, United Arab Emirates Talent Pal Full time

We are seeking a talented Regulatory Compliance Officer - External Quality to join our team at Talent Pal. As a key member of our organization, you will be responsible for ensuring the quality and safety of pharmaceutical products by overseeing quality assurance processes related to external contract manufacturers and local operating companies (LOCs).

Key Responsibilities:
  1. Develop and Implement Quality Management Systems: Develop and implement quality management systems that meet regulatory requirements and industry standards, collaborating with external partners.
  2. Conduct Regular Audits and Inspections: Conduct regular audits and inspections to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and company standards.
  3. Evaluate and Approve Contract Manufacturers: Evaluate and approve new contract manufacturers based on established quality criteria, ensuring they meet our high standards.
Quality Assurance and Compliance:
  1. Ensure Regulatory Compliance: Ensure adherence to relevant regulatory guidelines and industry standards among external partners, maintaining the highest level of quality and safety.
  2. Review and Approve Documentation: Review and approve quality agreements, Standard Operating Procedures (SOPs), batch disposition, and other documentation provided by external partners.
  3. Monitor and Manage Quality-Related Issues: Monitor and manage quality-related issues, including deviations, non-conformances, batch releases, and product recalls, in collaboration with external partners.
  4. Participate in Product Tech Transfer: Participate in product tech transfer to actively update and implement operational controls in batch records, ensuring alignment with production processes and regulatory standards.
  5. Provide Oversight of External CMO: Provide regular oversight of the external CMO by approving deviations and change controls, reviewing OOS and complaint investigations, overseeing Julphar production campaigns, and conducting APQR for manufactured products.
  6. Coordinate with CMO Quality Team: Coordinate with the CMO quality team to prepare the site for the Julphar routine audit, ensuring all relevant documentation, facilities, and personnel are thoroughly organized and ready for compliance verification.
Performance Monitoring:
  1. Track and Analyze KPIs: Track and analyze key performance indicators (KPIs) related to external quality, providing insights for improvement.
  2. Prepare and Present Reports: Prepare and present regular reports on quality performance, compliance status, and initiatives for improvement, highlighting areas of success and opportunity for growth.
  3. Identify Opportunities for Improvement: Identify opportunities for improvement in the quality management processes of external partners, fostering collaboration and driving excellence.
  4. Collaborate with External Partners: Collaborate with external partners to implement corrective and preventive actions (CAPAs) and other quality improvement initiatives, ensuring continuous improvement.
Qualifications:
  1. Hold a Bachelor's Degree in Pharmacy or Related Field: Hold a Bachelor's degree in Pharmacy, Chemistry, Biochemistry, or a related field, with a Master's degree or higher qualification preferred.
  2. Professional Certification in Quality Management: Possess professional certification in Quality Management or a related field, such as ASQ Certified Quality Manager.
  3. Minimum 7 Years of Experience in Quality Management: Have a minimum of 7 years of experience in quality management within the pharmaceutical industry, with a focus on external quality assurance.
  4. In-Depth Knowledge of GMP and Regulatory Standards: Possess in-depth knowledge of GMP, FDA regulations, and other relevant regulatory standards, ensuring expertise in regulatory compliance.
  5. Proven Experience in Conducting Audits and Managing Quality-Related Issues: Demonstrate proven experience in conducting audits and managing quality-related issues with external partners, showcasing exceptional leadership and problem-solving skills.
  6. Willingness to Travel: Be willing to travel as required for site audits and inspections, demonstrating adaptability and a commitment to excellence.
Core Competencies:
  1. Professional Knowledge in Quality Management Systems: Possess professional knowledge in quality management systems, including technical background and strong knowledge of GMP areas and regulatory standards.
  2. Completed Auditor Qualification Program: Have completed the Auditor Qualification program, ensuring expertise in auditing principles and practices.
  3. Ethical and Adheres to Organization Code of Conduct: Adhere to the organization's code of conduct and comply with the principles of auditing as listed in ISO 19011, section 4.
  4. Risk-Based Approach: Apply a risk-based approach to quality management, identifying and mitigating potential risks and hazards.
  5. Process Management: Demonstrate strong process management skills, including ability to work independently and manage multiple projects simultaneously.
  6. Strong Analytical, Problem-Solving, and Communication Skills: Possess strong analytical, problem-solving, and communication skills, ensuring effective collaboration and stakeholder engagement.
  7. Ability to Work Independently and Manage Multiple Projects: Demonstrate ability to work independently and manage multiple projects simultaneously, showcasing exceptional time and task management skills.
  8. Solid Knowledge of Quality Improvement Tools and Continuous Improvement Frameworks: Possess solid knowledge of quality improvement tools and continuous improvement frameworks, driving excellence and innovation.
  9. High Business Acumen: Exhibit high business acumen, having a strong understanding and practice of 'cost consciousness'.
  10. Excellent Result and Process Orientation: Demonstrate excellent result and process orientation, focusing on achievement and process excellence.
  11. High Adaptability and Change Management Skills: Possess high adaptability and change management skills, ensuring seamless transitions and continuous improvement.
  12. High Resolution Mindset with Good Decision-Making Skills: Possess a high resolution mindset with good decision-making skills, making informed decisions that drive excellence and results.
  13. Excellent Team Building and Time and Task Management Skills: Demonstrate excellent team building and time and task management skills, ensuring effective collaboration and project delivery.

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