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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