Website 23Century International Life Science Centre Sdn Bhd
Ø Implement and maintain a robust quality management system (QMS) to ensure compliance with applicable regulations and industry standards.
Ø Lead and manage the overall operations of the laboratory, including staffing, resource allocation, budgeting, and procurement of equipment and supplies.
Ø Provide effective management oversight to the Quality Control, Quality Assurance, and Production Departments, ensuring alignment with established standards, regulations, and collaborative interactions with other departments.
Ø Recruit, train, and supervise laboratory staff, ensuring their competence, professional development, and adherence to safety protocols.
Ø Establish and enforce quality assurance standards and procedures to ensure accurate and reliable testing and analysis of samples.
Ø Ensure manufacturing operations comply with pertinent procedures and batch records, upholding quality standards.
Ø Ensure the laboratory’s activities comply with relevant regulatory requirements, industry standards, and accreditation bodies.
Ø Oversee research initiatives and scientific projects, collaborating with researchers, analysts, and other stakeholders to advance knowledge and innovation.
Ø Oversee the maintenance and upkeep of facilities, including preventive and corrective maintenance tasks.
Ø Review and approve product release decisions, ensuring that products meet the required quality standards before release.
Ø Lead the validation of analytical methods, ensuring their accuracy, precision, and reliability for sample testing.
Ø Oversee data collection, analysis, and interpretation, ensuring proper documentation and reporting of results.
Ø Develop and manage the laboratory budget, optimize resource allocation and cost-effectiveness.
Ø Interact with clients, addressing inquiries, providing updates on testing progress, and ensuring client satisfaction.
Ø Identify opportunities for process optimization, efficiency enhancement, and technological advancements within the laboratory.
Ø Offer technical expertise across departments, spanning training, continuous process improvement, and product development.
Ø Address technical challenges, troubleshoot issues, and make informed decisions to ensure accurate and reliable testing outcomes.
Ø Manage the process of obtaining and maintaining laboratory accreditations, as well as preparing for and participating in audits.
Ø Contribute to the development of the laboratory’s strategic goals and initiatives, aligning with the organization’s objectives.
Ø Review quality documentation, such as standard operating procedures (SOPs), validation protocols, and quality reports.
Ø Identify and address potential risks with principles of quality risk management related to non-compliance with standards and regulations and develop mitigation strategies.
Ø Provide coverage for Quality Assurance activities when required.
Ø Report to top management on the performance of the QMS and any need for improvements.
Ø Coordinate and resolve quality management matters comprehensively, including the regular reporting of Key Performance Indicators (KPIs) to the CEO and designated stakeholders at 23 Century.
Performs other assigned duties as required to meet company objectives