· Review QMS related Standard Operating Procedure (SOPs),Protocols, forms to align with QMS.
· Review ‘Quality Agreement' with Client and negotiate the terms and conditions between client and company.
· Responsible to develop, implement and maintain the ISO standardizations that the company has to be certified ISO 9001:2015 as well as any other quality certifications required by the principals.
· Responsible to handle client audits and propose CAPA plan and follow and close out all findings within the timeline.
· Responsible to handle complaints related to the product quality and process deviation that has to be closed out successfully.
· 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 for safekeeping and editing of company quality related documentations.
· Prepare and provide accurate management reporting periodically in timely manner.
· 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.
· 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 retension 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
· 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.
· Prepares quality documentation and reports by collecting, analyzing and summarizing information
· Implements systems to compliance with third party industry standards.
· Leads response to Client and ISO auditors
· Ensure the current working procedure are in compliance with specified SOPs, GSDP, and ISO requirements.
· Responsible to conduct mock recall as per defined interval and ensure to follow procedure of recall in case of actual recall process.
· Any graduate preferably B. Pharm.
· At least five years working experiences in similar role
· Strong knowledge on pharmaceutical field
· Good working knowledge on distribution related international quality standards such as ISO, GSDP, BSI, etc.
· Strong knowledge on Problem-solving Skills, Leadership Skills,
· Good Interpersonal Communication Skills.
· Good Computer Skills with Myanmar Typing.
· Good English Proficiency .
· Reliable, Responsible, Accountable and Strong Commitment