As a Senior Officer in Quality Assurance and Quality Control (QA/QC), you will play a crucial role in ensuring the quality and compliance of our products and processes. You will be responsible for implementing and maintaining quality standards, conducting audits, and collaborating with cross-functional teams to drive continuous improvement.
Key responsibilities
Develop and implement quality assurance policies and procedures to ensure compliance with regulatory requirements and industry standards.
Conduct internal and external audits to evaluate the effectiveness of quality systems, identify areas for improvement, and facilitate corrective actions.
Ensure that all operations and products adhere to quality standards and regulations through regular inspections and testing procedures.
Collaborate with production, engineering, and other departments to address quality issues, optimize processes, and resolve non-conformances.
Participate in the development of quality metrics, data analysis, and reporting to monitor performance and drive quality improvement initiatives.
Manage the documentation process, including creation, review, and approval of quality-related documents such as SOPs, validation protocols, and batch records.
Support validation activities for equipment, processes, and systems to ensure compliance with regulatory requirements and industry best practices.
Conduct risk assessments and implement risk mitigation strategies to prevent quality and compliance issues.
Provide training and support to personnel on quality procedures, GMP practices, and quality system requirements.
Lead investigations into product quality issues, customer complaints, and non-conformances, and implement corrective and preventive actions.
Coordinate with suppliers and vendors to ensure the quality of incoming materials and components through supplier audits and evaluation programs.
Participate in the review and approval of change control requests to assess the impact on quality and ensure proper documentation and implementation.
Stay current with industry trends, regulations, and best practices to continuously improve the effectiveness and efficiency of the quality management system.
Contribute to the development and maintenance of quality-related documentation, including quality manuals, standard operating procedures, and work instructions.
Act as a representative during regulatory inspections and customer audits, ensuring compliance and addressing any quality-related inquiries.