As a Quality Management Officer, you will be responsible for implementing and maintaining our quality management system to ensure adherence to regulatory requirements and industry standards. You will play a critical role in monitoring and evaluating our manufacturing processes, conducting quality audits, and collaborating with cross-functional teams to drive continuous improvement initiatives. Your knowledge of pharmacy practices and regulations will be essential in maintaining our commitment to delivering safe and effective medications to our customers.
• Develop, implement, and maintain a comprehensive quality management system in accordance with applicable regulatory standards, such as FDA, EMA, and other relevant authorities.
• Conduct internal audits and assessments to ensure compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and other quality standards.
• Monitor and evaluate manufacturing processes, product quality, and documentation to identify areas for improvement and implement corrective and preventive actions (CAPAs) as necessary.
• Collaborate with cross-functional teams, including R&D, production, and regulatory affairs, to provide guidance on quality-related matters and ensure consistency across departments.
• Participate in the review and approval of batch records, specifications, and other quality-related documents.
• Investigate product quality issues, customer complaints, and non-conformances, and recommend and implement appropriate corrective actions.
• Support the preparation and execution of regulatory inspections and audits by external authorities, as required.
• Stay updated on relevant industry regulations, guidelines, and best practices to ensure compliance and recommend process enhancements.
• Bachelor's degree in Pharmacy.
• Proven experience in quality management, quality assurance, or a related role within the pharmaceutical industry.
• Strong knowledge of pharmaceutical manufacturing processes, GMP guidelines, and regulatory requirements.
• Familiarity with quality management systems (QMS) and their implementation, such as ISO 9001.
• Experience in conducting internal audits and managing CAPA processes.
• Excellent analytical skills and attention to detail, with the ability to interpret complex regulatory requirements and apply them effectively.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.