Position Overview:
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.
Responsibilities:
• 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.
Qualifications:
• 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.