Key Area

• Completion of action plan for audit findings with agreeable timeline
• Products quality related complaints are informed to Client/IBD in timely manner
• Temperature mapping for cold room including temperature mapping for under 25’ C and 30’C are performed every year.
• Monitor and Analyze which products are delivered to which customer in case of recall and inform the customer in timely manner and collect the product in efficient & effective manner
• Make sure that there is no critical external & internal audit findings

Other Area

• Ensure the current working procedures are in compliance with specified SOPs, GDP and ISO requirements
• Prepare QMS related Standard Operating Procedure (SOPs) and review the specified SOPs of other departments to improve the quality management system
• Handle the complaints related to the quality of products and any kind of non-conformities that impact on product quality to be resolved
• Responsible to follow up the audit findings, monitor corrective action plan to be effective
• Conduct self-inspection and internal auditing process to related departments to improve the quality management system
• Review and check the quality related validation process that performed by QA Executive and staffs
• Prepare and provide necessary information and data for management reporting in Quality related matters
• Train and supervise the QA Department staffs to be acknowledged to specified SOPs and processes and also train to other related departments in order to comply with specified SOPs and requirements
• Ensure department related documents are archived in accordance with the corporate document retention policy
• Perform any necessary changes of improvement to the organization to meet the ISO requirements.
• Practice to do mock recall as per defined interval and responsible to follow the procedure of recall if the real recall occurs.
• Perform any other duties as assigned by the Supervisor

• Strong knowledge on pharmaceutical products
• At least three years working experience in similar fields
• Any science graduates preferably B. Pharm
• Strong Knowledge on GSDP, QMS and ISO Standards.
• Good Business Communication Skills in English
• Good Computer Skills (MS Office Suite) with Myanmar Typing
• Strong Knowledge of Quality Assurance and QMSs
• Reliable, Responsible, Accountable and Strong Commitment