Senior Quality Assurance Officer - GLP

Responsibilities

Co-ordinate with laboratory staff who are responsible for carrying out audits and equipment calibrations. Ensure that the laboratory management quality system operates according to ISO17025 requirements and OECD GLP requuirements. Maintain SAMM accreditation and OECD GLP certification for the laboratory by successful managing of quality system. Act as QA officer for OECD GLP studies. Stay updated on industry trends and regulatory changes to ensure ongoing compliance and quality excellence. Managing and assisting with the resolution of issues relating to the ALS Quality system. Introducing and monitoring the system for statistical quality control of the laboratory data. Maintain quality documentation including SOPs, technical and quality manuals. Participating in the drafting and revision of quality procedures and work instructions. Ensuring that changes / amendments and new QWI are understood and complied with by laboratory staff. Instructing staff on the use of quality procedures. Undertaking or instructing staff to undertake the periodic calibration of specified equipment in ALS Laboratories. Managing issues related to or involving Dept of Standards, Malaysia Co-ordinating responses and actions from third party audits. Monitoring the laboratories performance in proficiency test studies. Handle customer complaint-Address customer complaint, gathering feedback and coordinating with relevant teams to solve issues and enhance customer satisfaction. Monitor and maintain the laboratory CAR system. Report monthly to the Senior Operations Manager with regard to key quality performance indicators. Performing other duties as requested by the General Manager and Senior Operations Manager

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