A Good Opportunity for ..
• Leads response to Client and ISO auditors.
• Implements systems to compliance with third party industry standards.
• Prepare and provide accurate management reporting periodically in timely manner.
• Responsible for safekeeping and editing of company quality related documentations.
• Review QMS related Standard Operating Procedure (SOPs), Protocols, forms to align with QMS.
• Prepares quality documentation and reports by collecting, analyzing and summarizing information.
• Review ‘Quality Agreement' with Client and negotiate the terms and conditions between client and company.
• Responsible to handle client audits and propose CAPA plan and follow and close out all findings within the timeline.
• Ensure the current working procedures are in compliance with specified SOPs, GSDP, and ISO requirements.essfully.
• Ensure cold-chain handling SOPs are in place and inform to clients in case of temperature and cold-room deviation and communicate with principal until final treatment of the product is instructed by the principal.
• Participate as internal auditor in QMS internal audit program and conduct internal auditing process to related departments to improve the quality management system and report audit findings to the Management.
• Responsible to conduct mock recall as per defined interval and ensure to follow procedure of recall in case of actual recall process.
• Perform any necessary changes of improvement to the organization to meet the ISO requirement.
• Ensure department related documents are archived in accordance with the corporate document retention policy.
• Key player in implementation and management of the Quality Management System.
• Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and review; preparing and completing action plans; implementing production, productivity, quality, completing audits, determining system improvements; implementing change.
• Responsible to develop, implement and maintain the ISO standardizations that the company has to be certified ISO9001:2015 as well as any other quality certifications required by the principals.
• Train and supervise the QA Department staffs to be acknowledged to specified SOPs and processes and also train staffs from other related departments in order to comply with specified SOPs and requirement.
• Develops quality assurance plans by conducting hazard analyses, identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures.