Process Lead - Quality Management System
Julphar
Date: 8 hours ago
City: Ras al-Khaimah
Contract type: Full time

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.
Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.
Detailed Job Description
Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.
Detailed Job Description
- Establish and manage Quality Management Systems (QMS), monitoring performance through KPIs, and regularly reporting outcomes to top management while ensuring the reflection of monthly data in the Quality Council.
- Provide insightful analysis of QMS & KPIs to assess site performance, identify areas for improvement, and support overall quality enhancement initiatives.
- Develop a framework for Corrective and Preventive Actions (CAPA) and ensure its alignment with Change Control, Complaints, Recalls, Deviations, Documentation, Job Descriptions, and Organizational Structures.
- Ensure compliance with the Site Master File, Quality Manual, ISO standards, and the Medical Check-Up system.
- Streamline systems and create a user-friendly environment while upholding high quality standards.
- Design and implement an effective CAPA system, ensuring root-cause analysis and problem-solving activities lead to appropriate corrective and preventive actions.
- Establish a compliant Quality Management System to facilitate timely, accurate, and sustained decision-making for appropriate and compliant outcomes.
- Oversee the company’s QMS, including Internal & Regulatory Audits, CAPA, Documentation/Change Control, Deviations, Risk Management, Customer Complaints, and Recall programs.
- Enhance QMS processes by revising and optimizing existing procedures to meet industry and regulatory standards.
- Manage the development, implementation, and certification of a fully compliant Quality Management System (ISO 9001).
- Ensure QMS compliance with relevant regulations and standards, staying updated on changes and ensuring ongoing compliance.
- Develop presentations and reporting mechanisms to effectively communicate QMS metrics.
- Administer the system for Job Descriptions and Organizational Structures (Organogram).
- Guide and support the QMS & Documentation team to ensure comprehensive coverage of all GMP change-related aspects.
- Lead the preparation, execution, and support of external regulatory inspections and customer audits.
- Oversee the implementation of the Quality Management Plan, providing recommendations for continuous improvement.
- Lead the Recall & Complaint management functions, ensuring timely and thorough resolution of issues.
- Provide leadership to achieve quality goals, continuously develop QMS processes, and design measures to assess the effectiveness of the Quality Management System, driving remediation efforts.
- Guide the development and enhancement of the Documentation team, ensuring best practices are followed in all aspects.
- Drive innovation within the QMS & Documentation teams, supporting digitalization efforts and compliance with industry standards.
- Support the implementation of Data Integrity principles to ensure accuracy and security of data.
- Ensure timely closure of all change controls, ensuring appropriate evidence and documentation are in place.
- Review CAPA actions for extensions and regulatory CAPA closure.
- Oversee strategic assessments and approvals for change controls.
- Address and resolve escalations related to batch printing issues.
- Manage escalations related to QMS and regulatory commitments, effectively communicating outcomes to upper management. Lead the preparation, management, execution and support of external regulatory agency inspections and customer audits.
- In-depth expertise in Quality Management Systems (QMS).
- Strong technical background in GMP-related areas, with comprehensive knowledge of regulatory standards and audit procedures.
- Effective leadership and motivational abilities for team management.
- Proficient problem-solving skills.
- Extensive technical knowledge in relevant fields.
- Strong communication and presentation abilities.
- Thorough understanding of quality improvement tools and continuous improvement methodologies.
- Excellent business acumen, with a focus on cost efficiency and financial awareness.
- Results- and process-driven, committed to achieving both personal and departmental goals.
- Adaptable with strong change management capabilities.
- Solution-oriented mindset with sound decision-making skills.
- Exceptional team-building skills, with strong time and task management for both personal and team success.
- Bachelor’s degree in pharmacy. A master’s degree or higher qualification is preferred.
- Professional certification in Quality Management or a related field (e.g., ASQ Certified Quality Manager) is a plus.
- A minimum of 7 years of experience in quality management within the pharmaceutical industry preferably in Quality Management systems,
- In-depth knowledge of GMP, FDA regulations, and other relevant regulatory standards.
- Strong analytical, problem-solving, and communication skills.
- Proficient in MS Word, Excel, and PowerPoint.
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