Implement and manage an integrated Quality Management System (QMS) while ensuring compliance with regulatory requirements. Assess the performance of facilities, processes, and the QMS to identify areas for improvement and develop action plans to achieve strategic objectives.
• Understand and adhere to Parkville's values/Policies and ensure all subordinates fully comply with values, regulations, policies, Code of Conduct, terms and conditions announced from the Human Resources Department.
• Implement and maintain an integrated Quality Management System (QMS) in accordance with cGMP and ISO requirements.
• Assess the performance of facilities, processes, and the QMS to measure and improve their effectiveness in achieving strategic objectives.
• Develop and execute quality improvement initiatives, adopting a specific approach to Continuous Quality Improvement.
• Conduct technical assessments of projects, perform gap analysis, and develop action plans to ensure compliance with quality system requirements.
• Provide quality leadership to assess the compliance of company processes, procedures, and quality system requirements.
• Attend external inspections conducted by regulatory authorities and certification bodies.
• Develop and manage all required Standard Operating Procedures (SOPs) to initiate a Total Quality Management (TQM) system within all operations.
• Collaborate with cross-functional facility operating teams to ensure the proper implementation of the QMS, including on-the-job training, internal audits, document control, GMP compliance monitoring, deviation investigations, change control assessments, supplier qualification, and product recall. Additionally, oversee the management of the documentation system control, batch release, CAPA system,and Quality Risk management.
Education
Bachelor’s degree in pharmaceutical sciences or Equivalent.
Experience
From 8 to 10 years of experience in same field with 2 years of experience as a quality Manager.