Plant Lead - Quality

Position Summary : Plant Lead - Quality

Location: DIC Dubai

Reporting: Plant Head

Role Context & Purpose

Plant Lead - Quality to lead Quality Assurance (QA) and Quality Control (QC) & Micro departments in pharmaceutical manufacturing facility. The ideal candidate will have a minimum of 10 years of experience in pharmaceutical manufacturing, proven expertise in SAP implementation, and a strong background in quality control, and a solid understanding of conducting and managing audits.

Key Reponsibilities

• Quality Assurance Leadership:
• Develop, implement, and oversee quality assurance policies and procedures to ensure compliance with pharmaceutical regulations, industry standards, and internal quality standards.
• Lead and mentor the QA team, providing guidance and support to ensure effective quality management practices.
• Monitor key quality metrics and implement corrective and preventive actions to address any issues and drive continuous improvement.
• SAP Implementation and Optimization:
• Manage the implementation, configuration, and optimization of SAP Quality Management (QM) modules to support quality assurance processes.
• Collaborate with IT and SAP consultants to ensure that SAP solutions are aligned with quality management needs and regulatory requirements.
• Provide training and ongoing support to QA and production teams on SAP QM functionalities and best practices.
• Audit Management:
• Prepare for, conduct, and oversee internal and external audits, including regulatory inspections and certifications.
• Address and resolve audit findings and non-conformities, implementing corrective actions as needed.
• Maintain up-to-date knowledge of audit requirements and industry standards to ensure compliance.
• Regulatory Compliance:
• Ensure all QA processes are compliant with Good Manufacturing Practices (GMP), FDA, EMA, and other relevant pharmaceutical regulations.
• Stay current with changes in regulatory requirements and ensure that QA processes are updated accordingly.
• Coordinate with regulatory bodies and ensure timely and accurate submission of required documentation.
• Continuous Improvement:
• Identify and lead initiatives to improve QA processes, enhance efficiency, and ensure the highest quality standards.
• Implement and promote best practices and continuous improvement methodologies within the QA department.
• Analyze quality data and trends to drive decision-making and process enhancements.
• Documentation and Reporting:
• Oversee the creation, maintenance, and review of quality documentation, including Standard Operating Procedures (SOPs), validation protocols, and quality reports.
• Ensure accurate and timely reporting of quality metrics and performance to senior management.
• Supplier and Vendor Management:
• Evaluate and monitor the quality of materials and components from suppliers to ensure compliance with specifications and standards.
• Collaborate with suppliers to address quality issues and drive improvements in the supply chain.
  
  

Candidate Specification

Education

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field. Advanced degree or relevant professional certification (e.g., CQE, Six Sigma) is a plus.
  
  

Experience

• Minimum of 10 years of experience in quality assurance within the pharmaceutical manufacturing industry, with a strong focus on quality control and inspection.
• Proven experience with SAP Quality Management (QM) module implementation and optimization.
• Extensive experience in conducting and managing audits, including internal and external regulatory inspections.
• Demonstrated expertise in quality control techniques, including sampling, inspection, and testing.
• In-depth knowledge of quality control standards and methodologies.
• Strong knowledge of cGMP, ICH, WHO, EMA, USFDA, and MHRA guidelines.
• Proven experience in handling global regulatory inspections of EMA, USFDA, and MHRA successfully.
• Expertise in Quality Management Systems, Risk Management, Data Integrity, and Industry 4.0 applications in QMS.
  
  

Skills

• Strong leadership, communication, and interpersonal skills.
• Deep understanding of pharmaceutical regulations, quality management systems, and GMP practices.
• Proficiency in SAP QM and related modules, with hands-on experience in SAP implementation.
• Excellent analytical and problem-solving abilities.
• Ability to drive continuous improvement and manage complex quality assurance processes.
• Excellent leadership, communication, and cross-cultural management skills.
  
  

Personal Attributes

• Detail-oriented with a strong commitment to maintaining high-quality standards.
• Proactive and results-driven, with a strategic approach to quality management.
• Adaptable and resilient, with the ability to manage change effectively.
• Strategic thinker with a proactive, results-oriented mindset.
• High integrity and commitment to compliance and ethical standards.
• Business mindset